EN 1041:2008+A1:2013

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View superseded by

Information supplied by the manufacturer of medical devices

Available format(s):

Superseded date: 14-05-2021

Language(s):

Published date: 25-09-2013

Publisher: Comite Europeen de Normalisation

Pure ENs are not available for sale, please purchase a suitable national adoption

Table of Contents - (Show below) - (Hide below)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Requirements for provision of information
6 Documentation
Annex A (informative) - Requirements and guidance for
        Directives 93/42/EEC and 90/385/EEC, as amended
Annex B (informative) - Guidance on alternative labelling for
        instructions for use (IFU)
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 93/42/EC
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 90/385/EC
Bibliography

Abstract - (Show below) - (Hide below)

This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).NOTEWhen national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.

General Product Information - (Show below) - (Hide below)

Development Note	2008 Edition Re-Issued in September 2013 & incorporates AMD 1 2013. (10/2013)
Document Type	Standard
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Superseded
Superseded By	EN ISO 20417:2021

National Adoptions - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ONORM EN 1041 : 2013	Identical
UNI EN 1041 : 2000	Identical
UNI CEI EN 1041 : 2013	Identical
I.S. EN 1041:2008+A1:2013	Identical
CEI UNI EN 1041 : 2014	Identical
NBN EN 1041 : 2008 + A1 2013	Identical
NF EN 1041 : 2008-10	Identical
SN EN 1041 : 2007-10	Identical
NS EN 1041 : 2008 + A1 2013	Identical
NEN EN 1041 : 2008 + A1 2013	Identical
DIN EN 1041:2013-12	Identical
BS EN 1041 : 2008	Identical
PN EN 1041 : 2010 + A1 2013	Identical
BS ISO 22526-1:2020	Identical
BS EN 1041:2008+A1:2013	Identical

Standards Referenced By This Book - (Show below) - (Hide below)

07/30165249 DC : 0	BS EN 15154-3 - EMERGENCY SAFETY SHOWERS - PART 3: NON PLUMBED-IN BODY SHOWERS
CAN/CSA-ISO 16571:16	SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
BS ISO 17966:2016	Assistive products for personal hygiene that support users. Requirements and test methods
I.S. EN 740:1999	ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
I.S. EN ISO 5364:2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS (ISO 5364:2016)
CSA ISO 5361 : 2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
UNI EN 15154-4 : 2009	EMERGENCY SAFETY SHOWERS - PART 4: NON PLUMBED-IN EYEWASH UNITS
UNI EN 868-5 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
BS EN ISO 14155:2011	Clinical investigation of medical devices for human subjects. Good clinical practice
15/30325867 DC : 0	BS EN 868-3 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 3: PAPER FOR USE IN THE MANUFACTURE OF PAPER BAGS (SPECIFIED IN EN 868-4) AND IN THE MANUFACTURE OF POUCHES AND REELS (SPECIFIED IN EN 868-5) - REQUIREMENTS AND TEST METHODS
DIN EN 14931 E : 2006	PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING
I.S. EN ISO 22523:2006	EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
12/30261215 DC : 0	BS EN 13060 - SMALL STEAM STERILIZERS
UNI EN 1865-4 : 2012	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR
EN ISO 7396-1:2016	Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
08/30184612 DC : DRAFT SEP 2008	BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
14/30295064 DC : 0	BS EN ISO 16672 - OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES
06/30112971 DC : DRAFT JULY 2006	ISO/IEC 62366 - MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
17/30336573 DC : 0	BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE
17/30336577 DC : 0	BS EN ISO 20697 - STERILE DRAINAGE CATHETERS AND ACCESSORY DEVICES FOR SINGLE USE
13/30242951 DC : 0	BS ISO 16571 - MEDICAL GAS SYSTEMS - SYSTEMS FOR EVACUATION OF PLUME GENERATED BY MEDICAL DEVICES
07/30166924 DC : DRAFT AUG 2007	BS EN 868-2 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
PREN 14180 : DRAFT 2012	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
DIN EN 1865-4:2012-09	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: FOLDABLE PATIENT TRANSFER CHAIR
08/30170025 DC : DRAFT AUG 2008	BS ISO 28620 - MEDICAL DEVICES - NON-ELECTRICALLY DRIVEN PORTABLE INFUSION DEVICES
DIN EN 15154-3:2009-07	EMERGENCY SAFETY SHOWERS - PART 3: NON PLUMBED-IN BODY SHOWERS
02/563808 DC : DRAFT SEP 2002	BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
02/563845 DC : DRAFT SEP 2002	BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
PREN 285 : DRAFT 2013	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
BS EN 14931:2006	Pressure vessels for human occupancy (PVHO). Multi-place pressure chambers for hyperbaric therapy. Performance, safety requirements and testing
DIN EN ISO 15223-1:2015-08 (Draft)	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
CSA Z10651-4 : 2008	LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
CSA ISO 11712 : 2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS
CSA Z10651.6 : 2006 : R2015	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
CSA Z18778 : 2008 : R2018	RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
I.S. EN 14931:2006	PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBER SYSTEMS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING
CSA Z10651.6 :2006	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
PREN 13060 : DRAFT 2012	SMALL STEAM STERILIZERS
CSA Z10535 : 2003	HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 8836:2015-02	Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014
CSA C22.2 No. 60601.2.12 : 2003	MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
I.S. EN 455-4:2009	MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION
AAMI ISO 5361 : 2012	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
BS EN ISO 7396-1:2016	Medical gas pipeline systems Pipeline systems for compressed medical gases and vacuum
ISO 5362:2006	Anaesthetic reservoir bags
BS EN 868-5:2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
DIN EN 868-10:2009-09	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
ISO 16571:2014	Systems for evacuation of plume generated by medical devices
CSA ISO 5362 : 2014	ANAESTHETIC RESERVOIR BAGS
CSA ISO 10079-3:14 (R2019)	Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (Adopted ISO 10079-3:2014, third edition, 2014-05-01)
DIN EN 868-10 E : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
I.S. EN 13795:2011	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
UNI EN 14683 : 2014	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
UNI CEI EN 980 : 2009	SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
I.S. EN 1865-2:2010	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
ISO 15798:2013	Ophthalmic implants Ophthalmic viscosurgical devices
EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
DIN EN 12470-1:2009-11	Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
DIN EN 1422:2014-08	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
DIN EN ISO 7376:2010-01	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
DIN EN 14254 E : 2004	IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
DIN EN 1642:2012-06	Dentistry - Medical devices for dentistry - Dental implants
DIN EN 1060-1:2010-03	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: GENERAL REQUIREMENTS
BS EN 1782 : 1998	TRACHEAL TUBES AND CONNECTORS
BS EN ISO 11979-4 : 2008	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008)
BS EN 13718-1:2014	Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances
UNE-EN 868-7:2017	Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
BS EN ISO 11979-9 : 2006	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
BS EN 13795-1 : 2002	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
ISO 10651-4:2002	Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
UNE-EN 868-2:2017	Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
BS EN ISO 22803:2005	Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file
BS EN 455-3:2015	Medical gloves for single use Requirements and testing for biological evaluation
UNE-EN ISO 14408:2016	Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)
BS EN 868-3:2017	Packaging for terminally sterilized medical devices Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5). Requirements and test methods
BS EN ISO 22523:2006	External limb prostheses and external orthoses. Requirements and test methods
BS EN ISO 14534:2015	Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
UNE-EN 868-6:2017	Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
BS EN 12342 : 1998	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
BS EN ISO 7376 : 2009-08	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
UNE-EN ISO 16672:2016	Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
BS EN 13544-3 : 2001	RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
DIN EN 1733:2003-02	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN 13014:2000	CONNECTIONS FOR GAS SAMPLING TUBES TO ANAESTHETIC AND RESPIRATORY EQUIPMENT
DIN EN 1422:1997-11	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
DIN EN 12342:1998-09	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
DIN EN 12342:2010-01	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
I.S. EN ISO 10651-4:2009	LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
I.S. EN ISO 18777:2009	TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
DIN EN 12470-3:2000-04	CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
DIN EN 14931:2006-08	Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
EN ISO 11979-4:2008/A1:2012	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008/AMD 1:2012)
EN 12011 : 1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
DIN EN 868-2:2017-05	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
EN 1282-2:2005+A1:2009	Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
EN ISO 5364:2016	Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
EN 12181 : 1998	OROPHARYNGEAL AIRWAYS
EN 13014:2000/AC:2002	CONNECTIONS FOR GAS SAMPLING TUBES TO ANAESTHETIC AND RESPIRATORY EQUIPMENT
EN 13544-2:2002+A1:2009	Respiratory therapy equipment - Part 2: Tubing and connectors
EN 62366 : 2008 AMD 1 2015	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
EN 1060-1:1995+A2:2009	Non-invasive sphygmomanometers - Part 1: General requirements
EN ISO 22523 : 2006	EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006)
DIN EN 868-4:2017-05	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
EN 12470-2:2000+A1:2009	Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
EN 12470-3:2000+A1:2009	Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
EN 12598 : 1999	OXYGEN MONITORS FOR PATIENT BREATHING MIXTURES - PARTICULAR REQUIREMENTS
EN 12470-1:2000+A1:2009	Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
EN ISO 5366-1:2009	Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
EN 13544-1:2007+A1:2009	Respiratory therapy equipment - Part 1: Nebulizing systems and their components
PREN 1422 : DRAFT 2011	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
03/306155 DC : DRAFT APR 2003	BS EN 14683 - SURGICAL MASKS - REQUIREMENTS AND TEST METHODS
10/30215051 DC : DRAFT JUNE 2010	BS EN 1865-4 - PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 4: MECHANICAL ASSISTED TRANSFER CHAIR
BS EN 15154-3:2009	EMERGENCY SAFETY SHOWERS - PART 3: NON PLUMBED-IN BODY SHOWERS
I.S. EN 12470-5:2003	CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE)
BS EN 455-4:2009	MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION
12/30262894 DC : 0	BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
PD ISO/TR 27809:2007	Health informatics. Measures for ensuring patient safety of health software
I.S. EN 16844:2017	AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
11/30243761 DC : 0	BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS
I.S. EN 1865-3:2012	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
17/30360908 DC : 0	BS EN 868-5 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
PREN 14683 : DRAFT 2017	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
PREN 13795-1 : DRAFT 2017	SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS
10/30215054 DC : DRAFT JUNE 2010	BS EN 1865-3 - PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
UNI EN ISO 7376 : 2009-10	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
DIN EN 1865-2:2015-05	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHER
11/30252448 DC : 0	BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
03/106945 DC : DRAFT APR 2003	BS EN ISO 14408 - TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION
PREN 868-7 : DRAFT 2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 7: ADHESIVE COATED PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
ISO 20696:2018	Sterile urethral catheters for single use
03/114562 DC : DRAFT SEP 2003	BS EN ISO 18777 - TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
ISO 17593:2007	Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
DIN EN ISO 8836 E : 2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
04/30057165 DC : 0	BS EN 14931 - PRESSURE VESSELS FOR HUMAN OCCUPANCY (PVHO) - MULTI-PLACE PRESSURE CHAMBERS FOR HYPERBARIC THERAPY - PERFORMANCE, SAFETY REQUIREMENTS AND TESTING
14/30295067 DC : 0	BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
13/30278952 DC : 0	BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
DD ENV 12718:2001	MEDICAL COMPRESSION HOSIERY
09/30192338 DC : 0	BS EN 1060-1:1996/A2 - NON-INVASIVE SPHYGMOMANOMETERS - PART 1: GENERAL REQUIREMENTS
13/30281504 DC : 0	BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
11/30212235 DC : 0	BS EN ISO 13504 - DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT
15/30280904 DC : 0	BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
07/30169940 DC : 0	BS EN ISO 11979-4 - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION
13/30278676 DC : 0	BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
03/111582 DC : DRAFT JULY 2003	BS EN ISO 18779 - DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
02/563832 DC : DRAFT SEP 2002	BS EN 1641 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
13/30276231 DC : 0	BS EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
14/30281863 DC : 0	BS EN ISO 5364 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
BS EN 45502-2-3:2010	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
09/30192341 DC : 0	BS EN 1060-2:1995/A1 - NON-INVASIVE SPHYGMOMANOMETERS - PART 2: SUPPLEMENTARY REQUIREMENTS FOR MECHANICAL SPHYGMOMANOMETERS
ISO/TR 27809:2007	Health informatics Measures for ensuring patient safety of health software
BS 5724-2.204(1999) : 1999	ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
CSA ISO 27427 : 2014	ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
03/111581 DC : DRAFT JULY 2003	BS EN ISO 18778 - INFANT MONITORS - PARTICULAR REQUIREMENTS
CSA Z10535 : 2003 : R2014	HOISTS FOR THE TRANSFER OF DISABLED PERSONS - REQUIREMENTS AND TEST METHODS
06/30106983 DC : 0	EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS OF MEDICAL DEVICES USED IN AIR AMBULANCES
CSA ISO 16628 : 2014	TRACHEOBRONCHIAL TUBES - SIZING AND MARKING
CSA Z8836 :2011	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
ANSI/AAMI/ISO 15223-1:2016	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
ISO 11249:2018	Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies
DIN EN 868-8:2009-09	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 7396-1:2016	MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
DIN EN ISO 11979-10:2014-12	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES (ISO 11979-10:2006 + AMD.1:2014)
I.S. EN 16372:2014	AESTHETIC SURGERY SERVICES
I.S. EN 62366-1:2015&AC:2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
UNE-EN ISO 14155:2012	Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
AAMI ISO 5367 : 2015	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
AAMI ISO 14408 : 2005	TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION
I.S. EN 13060:2014	SMALL STEAM STERILIZERS
AAMI ISO 8836 : 2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN 868-5:2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
DIN EN 868-5:2009-09	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS
EN 868-5:2009	Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
BS EN 13795:2011+A1:2013	Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
CSA IEC 62366-1 : 2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
CAN/CSA-ISO 10079-1:16	Medical suction equipment - Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2015, third edition, 2015-11-01)
PREN 868-3 : DRAFT 2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 3: PAPER FOR USE IN THE MANUFACTURE OF PAPER BAGS (SPECIFIED IN EN 868-4) AND IN THE MANUFACTURE OF POUCHES AND REELS (SPECIFIED IN EN 868-5) - REQUIREMENTS AND TEST METHODS
AAMI ISO 14155 : 2011	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
CSA ISO 11712:14 (R2019)	Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2009, first edition, 2009-05-15)
UNI EN ISO 14155 : 2012	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
DIN EN 868-9:2009-09	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
CSA ISO 10079-2 : 2014	MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT
NF EN 455-4 : 2009	MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION
BS EN ISO 5367:2014	Anaesthetic and respiratory equipment. Breathing sets and connectors
UNE-EN ISO 5367:2015	Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
BS EN 868-9:2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
PREN 12182 : 2009-06	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
UNI EN 15154-3 : 2009	EMERGENCY SAFETY SHOWERS - PART 3: NON PLUMBED-IN BODY SHOWERS
ISO 11199-2:2005	Walking aids manipulated by both arms Requirements and test methods Part 2: Rollators
UNI EN 868-9 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 9: UNCOATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
DIN EN 14683 E : 2014	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
BS EN 868-10:2009	PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
NF EN ISO 7376 : NOV 2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
ISO 8836:2014	Suction catheters for use in the respiratory tract
ISO 5367:2014	Anaesthetic and respiratory equipment — Breathing sets and connectors
DIN EN 1641:2010-02	Dentistry - Medical devices for dentistry - Materials
DIN EN 12182:2012-07	Assistive products for persons with disability - General requirements and test methods
DIN EN ISO 18779 E : 2005	MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
DIN EN 12470-2:2009-11	Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers (includes Amendment A1:2009)
DIN EN ISO 22803:2006-01	Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
DIN EN 1782:2009-12	TRACHEAL TUBES AND CONNECTORS
DIN EN ISO 18778 E : 2009	RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
DIN EN 1640:2010-02	Dentistry - Medical devices for dentistry - Equipment
DIN EN ISO 11199-2:2005-07	Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2005)
DIN EN ISO 4074:2016-05	NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
DIN EN ISO 18778:2009-08	Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
DIN EN ISO 11979-9:2014-12	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
DIN EN ISO 14408:2016-07	TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION (ISO 14408:2016)
DIN EN ISO 16672:2015-12	Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
DIN EN ISO 18777:2009-07	TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
DIN EN 13544-3:2010-01	Respiratory therapy equipment - Part 3: Air entrainment devices (includes Amendment A1:2009)
DIN EN ISO 11979-9 E : 2014	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006 + AMD.1:2014)
DIN EN 13544-2:2010-01	Respiratory therapy equipment - Part 2: Tubing and connectors (includes Amendment A1:2009)
DIN EN ISO 11979-4 E : 2013	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
BS EN 1640:2009	Dentistry. Medical devices for dentistry. Equipment
BS EN ISO 10079-2:2014	Medical suction equipment Manually powered suction equipment
BS EN 1639:2009	Dentistry. Medical devices for dentistry. Instruments
BS EN ISO 10651-4:2002	LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
BS EN 868-7:2017	Packaging for terminally sterilized medical devices Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
BS EN 12470-3 : 2000	CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
UNE-EN 868-4:2017	Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
I.S. EN ISO 14534:2015	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
I.S. EN 868-4:2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 5366-1:2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
I.S. EN 13544-3:2001	RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
I.S. EN ISO 22794:2009	DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
I.S. EN 868-3:2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 3: PAPER FOR USE IN THE MANUFACTURE OF PAPER BAGS (SPECIFIED IN EN 868-4) AND IN THE MANUFACTURE OF POUCHES AND REELS (SPECIFIED IN EN 868-5) - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 18778:2009	RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
I.S. EN 868-7:2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 7: ADHESIVE COATED PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
DIN EN 12470-5:2003-09	CLINICAL THERMOMETERS - PART 5: PERFORMANCE OF INFRA-RED EAR THERMOMETERS (WITH MAXIMUM DEVICE)
DIN EN 12470-4:2001-02	CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
I.S. EN 13544-2:2002	RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
ONORM EN ISO 11199-2 : 2005	WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 2: ROLLATORS
I.S. EN ISO 10079-2:2014	MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT (ISO 10079-2:2014)
I.S. EN ISO 11334-1:2007	ASSISTIVE PRODUCTS FOR WALKING MANIPULATED BY ONE ARM - REQUIREMENTS AND TEST METHODS - PART 1: ELBOW CRUTCHES
I.S. EN 12182:2012	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
I.S. EN 868-2:2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
DIN EN 1820:2009-12	ANAESTHETIC RESERVOIR BAGS
I.S. EN 1642:2011	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
I.S. EN 1640:2009	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
I.S. EN ISO 4074:2015	NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
I.S. EN 868-6:2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
I.S. EN 1639:2009	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
UNI EN 13718-1 : 2014	MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
I.S. EN 1422:2014	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
I.S. EN 1641:2009	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
I.S. EN 12470-2:2000	CLINICAL THERMOMETERS - PART 2: PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS
DIN EN 14180:2003-10	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
I.S. EN ISO 14408:2016	TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION (ISO 14408:2016)
I.S. EN ISO 10651-6:2009	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
I.S. EN 14180:2014	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
DIN EN ISO 10651-2:2011-06	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
I.S. EN 12470-1:2000	CLINICAL THERMOMETERS - PART 1: METALLIC LIQUID-IN-GLASS THERMOMETERS WITH MAXIMUM DEVICE
DIN EN 1789:2014-12	MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
I.S. EN 1282-2:2005	TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
I.S. EN ISO 18779:2005	MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
I.S. EN ISO 11199-2:2005	WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 2: ROLLATORS
I.S. EN ISO 16672:2015	OPHTHALMIC IMPLANTS - OCULAR ENDOTAMPONADES (ISO 16672:2015)
I.S. EN ISO 10079-3:2014	MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE (ISO 10079-3:2014)
DIN EN ISO 5366-1:2009-07	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
UNI EN 1642 : 2012	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
NF EN 13544-3 : 2002 + A1 2009	RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
BS ISO 15198:2004	Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
DIN EN 13795:2013-10	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
ISO/TS 16628:2003	Tracheobronchial tubes Recommendations for size designation and labelling
13/30260084 DC : 0	BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS
I.S. EN 285:2015	STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
BS ISO 11712:2009	Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors
08/30184602 DC : DRAFT SEP 2008	BS EN 1639 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
14/30289772 DC : 0	BS EN 1789:2007+A1:2010/A2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
15/30317874 DC : 0	BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
BS ISO 25841:2017	Female condoms. Requirements and test methods
BS EN ISO 8836:2014	Suction catheters for use in the respiratory tract
UNE-EN 1865-1:2011	Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
14/30290166 DC : 0	BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
UNI EN ISO 11979-10 : 2015	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES
I.S. EN 12181:1998	OROPHARYNGEAL AIRWAYS
BS ISO 18190:2016	Anaesthetic and respiratory equipment. General requirements for airways and related equipment
00/563810 DC : DRAFT AUG 2000	BS EN 13544-2 RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
BS EN ISO 5364:2016	Anaesthetic and respiratory equipment. Oropharyngeal airways
UNI EN ISO 5367 : 2015	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
CAN/CSA-ISO 5364:16	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
UNE-EN ISO 5364:2017	Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016)
UNI EN 455-4 : 2009	MEDICAL GLOVES FOR SINGLE USE - PART 4: REQUIREMENTS AND TESTING FOR SHELF LIFE DETERMINATION
13/30255929 DC : 0	BS EN ISO 7396-1 - MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM
01/564180 DC : DRAFT OCT 2001	BS EN 14254 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
ISO 15198:2004	Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
DD ENV 12719:2001	MEDICAL THROMBOSIS PROPHYLAXIS HOSIERY
12/30251858 DC : 0	BS ISO 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS
09/30201992 DC : 0	BS EN 12182 - ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
15/30325864 DC : 0	BS EN 868-7 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 7: ADHESIVE COATED PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
BS EN 60601-2-12:2006	Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators
BS ISO 16142-1:2016	Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
09/30207531 DC : 0	BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
BS ISO 28620:2010	Medical devices. Non-electrically driven portable infusion devices
08/30176106 DC : DRAFT MAR 2008	BS EN 1865-2 - SPECIFICATION FOR PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 2: POWER ASSISTED STRETCHERS
I.S. EN 16844:2017+A2:2019	Aesthetic medicine services - Non-surgical medical treatments
09/30176675 DC : 0	BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
08/30184615 DC : DRAFT SEP 2008	BS EN 1642 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
UNE-EN 16372:2015	Aesthetic surgery services
ISO 16142-1:2016	Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
03/317861 DC : DRAFT OCT 2003	EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
AAMI IEC 62366 : 2015	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
PREN 868-8 : DRAFT 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
DD ISO/TS 16628:2003	TRACHEOBRONCHIAL TUBES - RECOMMENDATIONS FOR SIZE DESIGNATION AND LABELLING
CSA Z18779 : 2008 : R2013	MEDICAL DEVICES FOR CONSERVING OXYGEN AND OXYGEN MIXTURES - PARTICULAR REQUIREMENTS
CSA IEC 62366 : 2014	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
CSA Z8836 : 2011 : FR	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
UNI EN ISO 8836 : 2015	A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
03/103294 DC : DRAFT JAN 2003	BS EN ISO 10651-6 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME CARE VENTILATORY SUPPORT DEVICES
UNE-EN ISO 8836:2015	Suction catheters for use in the respiratory tract (ISO 8836:2014)
08/30178723 DC : DRAFT AUG 2008	BS ISO 15798 - OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES
03/101659 DC : DRAFT JAN 2003	ISO 22803 - DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE
CSA Z10651-4 : 2008 : R2013	LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
DIN EN ISO 14155:2012-01	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
CSA Z10651.6 : 2006	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
CSA Z18778 :2008	RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
UNI EN 868-10 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
DIN EN 14683:2014-07	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
UNI EN 13795 : 2013	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
CSA Z8836 : 2011 : R2015	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN ISO 5361:2016	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014)
CEI UNI EN 15986 : 2011	SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
CEI EN 60601-2-12 : 2007	MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
EN ISO 16671:2015/A1:2017	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015/AMD 1:2017)
I.S. EN 15986:2011	SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
EN 13060:2014	Small steam sterilizers
I.S. EN 62366-1:2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
BS EN ISO 15223-1:2016	Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied General requirements
BS EN 62366 : 2008	MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
UNI EN ISO 5361 : 2013	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
DIN EN ISO 7396-1:2016-09	MEDICAL GAS PIPELINE SYSTEMS - PART 1: PIPELINE SYSTEMS FOR COMPRESSED MEDICAL GASES AND VACUUM (ISO 7396-1:2016)
CSA ISO 10079-3 : 2014	MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE
CEN/TR 15640:2007	Health informatics - Measures for ensuring the patient safety of health software
AAMI ISO 5362 : 2006	ANAESTHETIC RESERVOIR BAGS
I.S. EN 868-8:2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
PREN 868-2 : DRAFT 2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
UNI EN ISO 5364 : 2011	ANAESTHETIC AND RESPIRATORY EQUIPMENT - OROPHARYNGEAL AIRWAYS
BIS IS/ISO 11979-4 : 2008	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELING INFORMATION
EN 16844:2017	Aesthetic medicine services - Non-surgical medical treatments
ISO 17218:2014	Sterile acupuncture needles for single use
ISO 25841:2017	Female condoms — Requirements and test methods
UNI EN 868-8 : 2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 16671:2015	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015)
I.S. EN ISO 8836:2014	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
DIN EN ISO 18777 E : 2009	TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
DIN EN ISO 22523:2007-04	External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
DIN EN 12470-3:2009-11	CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
DIN EN ISO 22794:2009-11	Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
DIN EN 12470-4:2009-11	CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
DIN EN ISO 11199-3:2005-07	WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 3: WALKING TABLES
DIN EN ISO 10651-6:2011-06	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
DIN EN ISO 10651-4:2009-08	Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
DIN EN 13060:2015-03	SMALL STEAM STERILIZERS
DIN EN 1639:2010-02	Dentistry - Medical devices for dentistry - Instruments
DIN EN 13544-1:2009-12	RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
DIN EN 455-3:2015-07	MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
DIN EN 13718-1:2014-12	MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
DIN EN ISO 10079-3:2014-09	Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
DIN EN 455-2:2015-07	MEDICAL GLOVES FOR SINGLE USE - PART 2: REQUIREMENTS AND TESTING FOR PHYSICAL PROPERTIES
DIN EN 285:2016-05	Sterilization - Steam sterilizers - Large sterilizers
DIN EN ISO 11334-1:2007-04	Assistive products for walking manipulated by one arm - Requirements and test methods - Part 1: Elbow crutches (ISO 11334-1:2007)
ISO 18779:2005	Medical devices for conserving oxygen and oxygen mixtures Particular requirements
BS EN ISO 11334-1:2007	Assistive products for walking manipulated by one arm. Requirements and test methods Elbow crutches
ISO 5364:2016	Anaesthetic and respiratory equipment — Oropharyngeal airways
BS EN 12470-5:2003	Clinical thermometers Performance of infra-red ear thermometers (with maximum device)
ISO 5366-1:2000	Anaesthetic and respiratory equipment Tracheostomy tubes Part 1: Tubes and connectors for use in adults
ISO 22794:2007	Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
EN 868-10:2009	Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
I.S. EN 1789:2007	MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
EN 868-8:2009	Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
EN ISO 7376:2009	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)
EN 1789:2007+A2:2014	Medical vehicles and their equipment - Road ambulances
I.S. EN ISO 7376:2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
EN ISO 11979-9:2006/A1:2014	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
I.S. EN 868-10:2009	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 10: ADHESIVE COATED NONWOVEN MATERIALS OF POLYOLEFINES - REQUIREMENTS AND TEST METHODS
UNE-EN 1282-2:2006	Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
I.S. EN ISO 11979-4:2008	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008)
I.S. EN 13544-1:2007	RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
EN ISO 8836:2014	Suction catheters for use in the respiratory tract (ISO 8836:2014)
EN ISO 14155:2011/AC:2011	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
I.S. EN 1820:2005	ANAESTHETIC RESERVOIR BAGS
UNE-EN 1782:1998	TRACHEAL TUBES AND CONNECTORS.
EN 868-9:2009	Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
EN 62366-1:2015/AC:2015	MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015)
EN 868-7:2017	Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
EN 13795-1:2002+A1:2009	Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
EN 1782:1998+A1:2009	Tracheal tubes and connectors
UNI EN 12470-3 : 2009	CLINICAL THERMOMETERS - PART 3: PERFORMANCE OF COMPACT ELECTRICAL THERMOMETERS (NON-PREDICTIVE AND PREDICTIVE) WITH MAXIMUM DEVICE
UNI EN 12470-4 : 2009	CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
UNI EN 1060-2 : 2010	NON-INVASIVE SPHYGMOMANOMETERS - PART 2: SUPPLEMENTARY REQUIREMENTS FOR MECHANICAL SPHYGMOMANOMETERS
UNI EN 13544-3 : 2009	RESPIRATORY THERAPY EQUIPMENT - PART 3: AIR ENTRAINMENT DEVICES
UNI EN 1060-1 : 2010	NON-INVASIVE SPHYGMOMANOMETERS - PART 1: GENERAL REQUIREMENTS
UNI EN 1641 : 2010	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
UNI EN 1640 : 2010	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
UNI EN 1639 : 2010	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS
UNI EN ISO 10651-2 : 2009	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR- DEPENDENT PATIENTS
UNI EN ISO 7396-2 : 2007	MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
UNI EN 12470-1 : 2009	CLINICAL THERMOMETERS - PART 1: METALLIC LIQUID-IN-GLASS THERMOMETERS WITH MAXIMUM DEVICE
UNI EN ISO 11979-4 : 2012	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION
UNI EN ISO 11979-9 : 2014	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
UNI EN 12470-2 : 2009	CLINICAL THERMOMETERS - PART 2: PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS
UNI EN ISO 5366-1 : 2009	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
UNI EN ISO 10079-3 : 2014	MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM A VACUUM OR POSITIVE PRESSURE GAS SOURCE
UNI EN 1282-2 : 2009	TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
EN 868-4:2017	Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
UNI EN ISO 18777 : 2009	TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
UNI EN ISO 10079-2 : 2014	MEDICAL SUCTION EQUIPMENT - PART 2: MANUALLY POWERED SUCTION EQUIPMENT
UNI EN 13544-1 : 2009	RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
UNI EN 12342 : 2009	BREATHING TUBES INTENDED FOR USE WITH ANAESTHETIC APPARATUS AND VENTILATORS
UNI CEI EN 45502-2-3 : 2010	ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
UNI EN 13544-2 : 2009	RESPIRATORY THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS
UNI EN ISO 10651-6 : 2009	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 6: HOME-CARE VENTILATORY SUPPORT DEVICES
UNI EN ISO 10651-4 : 2009	LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
UNI EN ISO 18778 : 2009	RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
UNI EN 14180 : 2014	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
UNI EN 12182 : 2012	ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS
UNI EN 1422 : 2014	STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
UNI EN 1820 : 2009	ANAESTHETIC RESERVOIR BAGS
UNI EN 13795-1 : 2009	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
UNI EN 1782 : 2009	TRACHEAL TUBES AND CONNECTORS
UNE-EN ISO 5361:2017	Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
BS ISO 16571:2014	Systems for evacuation of plume generated by medical devices
15/30325855 DC : 0	BS EN 868-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
15/30282343 DC : 0	BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES
15/30325469 DC : 0	BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
PREN 17180 : DRAFT 2017	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
14/30244508 DC : 0	BS EN 62366-1 - MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
07/30147554 DC : DRAFT SEP 2007	BS ISO 16628 - TRACHEOBRONCHIAL TUBES - SIZING AND MARKING
BS EN ISO 11979-10 : 2006	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 10: PHAKIC INTRAOCULAR LENSES
09/30190221 DC : 0	BS EN 13795 - SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
I.S. EN ISO 7396-2:2007	MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
DIN EN 1865-1:2015-08	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT
I.S. EN 1733:2002	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
I.S. EN 12011:1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
07/30147572 DC : DRAFT SEP 2007	BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
02/560790 DC : DRAFT FEB 2002	BS EN ISO 16671 - OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
02/563809 DC : DRAFT SEP 2002	BS EN 980 - GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
PREN 455-3 : DRAFT 2013	MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
PD CEN/TR 15640:2007	HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE
ISO 20697:2018	Sterile drainage catheters and accessory devices for single use
13/30259011 DC : 0	BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
ISO 18746:2016	Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use
14/30281859 DC : 0	BS ISO 5361 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
UNE-EN 15986:2011	Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
02/564996 DC : DRAFT NOV 2002	BS EN ISO 16201 - TECHNICAL AIDS FOR DISABLED PERSONS - REMOTE CONTROL SYSTEMS
14/30302761 DC : 0	BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS)
MEDDEV 2.5-7 : REV 1 : 1998	GUIDELINES FOR CONFORMITY ASSESSMENT OF BREAST IMPLANTS ACCORDING TO DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES
BS ISO 14408:1998	TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION
14/30257546 DC : 0	BS ISO 17966 - ASSISTIVE PRODUCTS FOR PERSONAL HYGIENE THAT SUPPORT USERS - REQUIREMENTS AND TEST METHODS
09/30205582 DC : 0	BS EN 15986 - SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
BS EN ISO 5361:2016	Anaesthetic and respiratory equipment. Tracheal tubes and connectors
18/30349834 DC : 0	BS ISO 21802 - ASSISTIVE PRODUCTS - GUIDELINES ON COGNITIVE ACCESSIBILITY - DAILY TIME MANAGEMENT
12/30244415 DC : DRAFT APR 2012	BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS
PREN 868-6 : DRAFT 2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
BS EN 1865-4:2012	Patient handling equipment used in road ambulances Foldable patient transfer chair
DIN EN 1865-3:2015-05	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
03/103293 DC : DRAFT JAN 2003	BS EN ISO 10651-2 - LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
UNE-EN 1865-4:2012	Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
CSA Z18778 : 2008 : R2013	RESPIRATORY EQUIPMENT - INFANT MONITORS - PARTICULAR REQUIREMENTS
CAN/CSA-Z18777-08 (R2018)	Transportable Liquid Oxygen Systems for Medical Use - Particular Requirements (Adopted ISO 18777:2005, first edition, 2005-02-15, with Canadian deviations)
CSA Z7376 : 2012	ANAESTHETIC AND RESPIRATORY EQUIPMENT - LARYNGOSCOPES FOR TRACHEAL INTUBATION
02/563818 DC : DRAFT SEP 2002	BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
BS ISO 16628:2008	Tracheobronchial tubes. Sizing and marking
CSA Z10651.2: 2006	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
CSA Z18777 : 2008	TRANSPORTABLE LIQUID OXYGEN SYSTEMS FOR MEDICAL USE - PARTICULAR REQUIREMENTS
CAN/CSA-Z10651-4-08 (R2018)	Lung Ventilators - Part 4: Particular Requirements for Operator-Powered Resuscitators (Adopted ISO 10651-4:2002, first edition, 2002-03-01, with Canadian deviations)
BS EN 14683:2014	Medical face masks. Requirements and test methods
UNI CEI EN 15986 : 2011	SYMBOL FOR USE IN THE LABELLING OF MEDICAL DEVICES - REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES CONTAINING PHTHALATES
AAMI ISO 10651-4 : 1999	LUNG VENTILATORS - PART 4: PARTICULAR REQUIREMENTS FOR OPERATOR-POWERED RESUSCITATORS
I.S. EN ISO 15798:2013	OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
I.S. EN 1865-1:2010	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 1: GENERAL STRETCHER SYSTEMS AND PATIENT HANDLING EQUIPMENT
DIN EN ISO 5367:2015-02	ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
PREN 868-4 : DRAFT 2015	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS
ISO 16671:2015	Ophthalmic implants — Irrigating solutions for ophthalmic surgery
ISO 17966:2016	Assistive products for personal hygiene that support users Requirements and test methods
17/30359567 DC : 0	BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 15223-1:2016	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
UNE-EN 13060:2015	Small steam sterilizers
UNE-EN ISO 7396-1:2016	Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
EN 14683:2014	Medical face masks - Requirements and test methods
BS EN ISO 16671 : 2015	OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
ISO 14708-7:2013	Implants for surgery Active implantable medical devices Part 7: Particular requirements for cochlear implant systems
ISO 7396-1:2016	Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
I.S. EN 14683:2014	MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS
I.S. EN 14254:2004	IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS
I.S. EN 60601-2-12:2006	MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS
DIN EN 14180:2014-09	STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
DIN EN 868-6:2015-08 (Draft)	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS
DIN EN ISO 10079-1:2016-05	MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015)
DIN EN ISO 14534:2015-08	Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
DIN EN ISO 10079-2:2014-09	Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014
BS EN 12181:1998	OROPHARYNGEAL AIRWAYS
ISO 18778:2005	Respiratory equipment — Infant monitors — Particular requirements
BS EN 868-2:2017	Packaging for terminally sterilized medical devices Sterilization wrap. Requirements and test methods
ISO 10651-2:2004	Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
UNE-EN ISO 10079-3:2014	Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
BS EN ISO 11199-3:2005	Walking aids manipulated by both arms. Requirements and test methods Walking tables
BS EN 1820:2005	Anaesthetic reservoir bags
ISO 7376:2009	Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation
BS EN 1615:2000	Enteral feeding catheters and enteral giving sets for single use and their connectors. Design and testing
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
BS EN ISO 10651-6:2009	Lung ventilators for medical use. Particular requirements for basic safety and essential performance Home-care ventilatory support devices
DIN EN ISO 11979-4:2013-01	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
ISO 11979-9:2006	Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses
BS EN 13544-1 : 2007	RESPIRATORY THERAPY EQUIPMENT - PART 1: NEBULIZING SYSTEMS AND THEIR COMPONENTS
BS EN 12011:1998	INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
UNE-EN 13795:2011	Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
BS EN ISO 10079-3:2014	Medical suction equipment Suction equipment powered from a vacuum or positive pressure gas source
BS EN ISO 18778:2009	Respiratory equipment. Infant monitors. Particular requirements
UNE-EN ISO 4074:2016	Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
UNE-EN ISO 15223-1:2017	Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
BS EN 455-2:2015	Medical gloves for single use Requirements and testing for physical properties
BS EN 14254:2004	In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans
UNE-EN 13544-3:2001	Respiratory therapy equipment - Part 3: Air entrainment devices.
UNE-EN 455-3:2015	Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 13718-1:2014	Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
BS EN 1789 : 2007	MEDICAL VEHICLES AND THEIR EQUIPMENT - ROAD AMBULANCES
ISO 14408:2016	Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information
BS EN 12470-4 : 2001	CLINICAL THERMOMETERS - PART 4: PERFORMANCE OF ELECTRICAL THERMOMETERS FOR CONTINUOUS MEASUREMENT
ISO 16672:2015	Ophthalmic implants Ocular endotamponades
I.S. EN 13718-1:2014	MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
BS EN 13060 : 2014	SMALL STEAM STERILIZERS
UNE-EN 1642:2012	Dentistry - Medical devices for dentistry - Dental implants
UNE-EN 1789:2007	Medical vehicles and their equipment - Road ambulances
ISO 14534:2011	Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
UNE-EN ISO 14534:2015	Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
ISO 18777:2005	Transportable liquid oxygen systems for medical use — Particular requirements
BS EN ISO 10651-2:2004	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
BS EN 285:2015	Sterilization. Steam sterilizers. Large sterilizers
ISO 10651-6:2004	Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
BS EN ISO 14408:2016	Tracheal tubes designed for laser surgery. Requirements for marking and accompanying information
ISO 5361:2016	Anaesthetic and respiratory equipment — Tracheal tubes and connectors
I.S. EN 455-3:2015	MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
I.S. EN 455-2:2015	MEDICAL GLOVES FOR SINGLE USE - PART 2: REQUIREMENTS AND TESTING FOR PHYSICAL PROPERTIES
BS EN 1865:2000	SPECIFICATIONS FOR STRETCHERS AND OTHER PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES
BS EN 12470-2 : 2001	CLINICAL THERMOMETERS - PHASE CHANGE TYPE (DOT MATRIX) THERMOMETERS
BS EN 740:1999	ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
BS EN ISO 11199-2:2005	Walking aids manipulated by both arms. Requirements and test methods Rollators
ISO 22523:2006	External limb prostheses and external orthoses — Requirements and test methods
ISO 11979-4:2008	Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
UNE-EN 1820:2006	Anaesthetic reservoir bags (ISO 5362:2000, modified)
ISO 11334-1:2007	Assistive products for walking manipulated by one arm Requirements and test methods Part 1: Elbow crutches
BS EN 14180:2014	Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
UNE-EN 45502-2-3:2010	Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
UNE-EN 455-2:2015	Medical gloves for single use - Part 2: Requirements and testing for physical properties
BS EN 1282-2 : 2005	TRACHEOSTOMY TUBES - PART 2: PAEDIATRIC TUBES
BS EN 868-4:2017	Packaging for terminally sterilized medical devices Paper bags. Requirements and test methods
UNE-EN ISO 10079-2:2014	Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
I.S. EN ISO 11979-9:2006	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES (ISO 11979-9:2006)
ISO 10079-3:2014	Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
BS EN ISO 5366-1:2004	ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART 1: TUBES AND CONNECTORS FOR USE IN ADULTS
ISO 4074:2015	Natural rubber latex male condoms Requirements and test methods
BS EN ISO 22794:2009	Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file
BS EN 868-6:2017	Packaging for terminally sterilized medical devices Paper for low temperature sterilization processes. Requirements and test methods
ISO 11199-3:2005	Walking aids manipulated by both arms Requirements and test methods Part 3: Walking tables
BS EN 12182:2012	Assistive products for persons with disability. General requirements and test methods
BS EN 12523:1999	External limb prostheses and external orthoses. Requirements and test methods
I.S. EN 13795-1:2002	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
BS EN 1641:2004	DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
DIN EN 13795-1 E : 2009	SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
EN 15154-3:2009	Emergency safety showers - Part 3: Non plumbed-in body showers
EN 15154-4:2009	Emergency safety showers - Part 4: Non plumbed-in eyewash units
EN 868-2:2017	Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 16372:2014	Aesthetic surgery services
EN ISO 11199-3 : 2005	WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 3: WALKING TABLES
EN ISO 10651-4:2009	Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
EN 1060-2:1995+A1:2009	Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
EN 1865-2:2010+A1:2015 (edition 2)	Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
EN ISO 5361:2016	Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
EN 1733 : 2002	SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
EN ISO 10651-2:2009	Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
EN 1820:2005+A1:2009	Anaesthetic reservoir bags (ISO 5362:2000, modified)
EN ISO 22803:2005	Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)
EN 13795:2011+A1:2013	Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
EN 12342:1998+A1:2009	Breathing tubes intended for use with anaesthetic apparatus and ventilators
EN ISO 10651-6:2009	Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
EN ISO 10079-2:2014	Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
EN 1641:2009	Dentistry - Medical devices for dentistry - Materials
EN ISO 18779:2005	Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
EN 45502-2-3:2010	Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
EN 1865 : 1999	SPECIFICATIONS FOR STRETCHERS AND OTHER PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES
EN 1642:2011	Dentistry - Medical devices for dentistry - Dental implants
EN 1639:2009	Dentistry - Medical devices for dentistry - Instruments
EN 455-2:2015	Medical gloves for single use - Part 2: Requirements and testing for physical properties
EN 1865-4:2012 (edition 2)	Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
EN ISO 18777:2009	Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
EN 740:1998/A1:2004	ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS
EN ISO 10079-3:2014	Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
EN 14931:2006	Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
EN 1422:2014	Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 1640:2009	Dentistry - Medical devices for dentistry - Equipment
EN 455-3:2015	Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
EN 1865-3:2012+A1:2015 (edition 2)	Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
EN ISO 22794:2009	Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)
EN ISO 14408:2016	Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2016)
EN 12470-4:2000+A1:2009	Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
EN 1865-1:2010+A1:2015	Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
EN ISO 14534:2015	Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
EN 15986:2011	Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN ISO 18778:2009	Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
EN 14180:2014	Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 455-4:2009	Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
EN ISO 11334-1:2007	Assistive products for walking manipulated by one arm - Requirements and test methods - Part 1: Elbow crutches (ISO 11334-1:2007)
EN 980:2008	Symbols for use in the labelling of medical devices
EN 868-6:2017	Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN 868-3:2017	Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
EN ISO 7396-2:2007	Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
EN ISO 4074:2015	Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
EN ISO 5367:2014	Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
BS EN 1865-3 : 2012	PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 3: HEAVY DUTY STRETCHER
08/30184608 DC : DRAFT SEP 2008	BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
BS ISO 17218:2014	Sterile acupuncture needles for single use
02/563797 DC : DRAFT SEP 2002	BS EN ISO 11199-3 - WALKING AIDS MANIPULATED BY BOTH ARMS - REQUIREMENTS AND TEST METHODS - PART 3: WALKING TABLES
BS EN 15154-4:2009	EMERGENCY SAFETY SHOWERS - PART 4: NON PLUMBED-IN EYEWASH UNITS
DIN EN 15154-4:2009-07	EMERGENCY SAFETY SHOWERS - PART 4: NON PLUMBED-IN EYEWASH UNITS
I.S. EN 980:2008	SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
BS EN 16372:2014	Aesthetic surgery services
I.S. EN 15154-4:2009	EMERGENCY SAFETY SHOWERS - PART 4: NON PLUMBED-IN EYEWASH UNITS
I.S. EN ISO 14155:2011	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
S.R. CEN TR 15640:2007	HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE
I.S. EN ISO 10651-2:2009	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 2: HOME CARE VENTILATORS FOR VENTILATOR-DEPENDENT PATIENTS
BS ISO 27427:2013	Anaesthetic and respiratory equipment. Nebulizing systems and components
BS EN 15986:2011	Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
I.S. EN 15154-3:2009	EMERGENCY SAFETY SHOWERS - PART 3: NON PLUMBED-IN BODY SHOWERS
BS ISO 17593:2007	Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
12/30210881 DC : DRAFT APR 2012	BS EN ISO 5367 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS
12/30260949 DC : 0	BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHOD
14/30281856 DC : 0	BS EN ISO 14408 - TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION
13/30268585 DC : 0	BS EN ISO 10079-1 - MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT