03/104519 DC : DRAFT FEB 2003
|
BS ISO 11737-3 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 3: GUIDANCE ON EVALUATION AND INTERPRETATION OF BIOBURDEN DATA |
03/108542 DC : DRAFT MAY 2003
|
BS EN ISO 11140-1 - STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
I.S. EN ISO 5840:2009
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
16/30310656 DC : 0
|
BS EN ISO 18369-1 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: VOCABULARY, CLASSIFICATION SYSTEM AND RECOMMENDATIONS FOR LABELLING SPECIFICATIONS |
08/30184486 DC : DRAFT JUNE 2008
|
BS EN ISO 1135-4 - TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE |
ASTM F 2407 : 2006 : R2013 : EDT 1
|
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
13/30276989 DC : 0
|
BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS |
I.S. EN 13503-8:2000
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
02/564514 DC : DRAFT OCT 2002
|
BS EN ISO 8536-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED |
DIN EN ISO 7197:2009-08
|
NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
AAMI ISO 11137-1 : 2006 : R2010
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
08/30170025 DC : DRAFT AUG 2008
|
BS ISO 28620 - MEDICAL DEVICES - NON-ELECTRICALLY DRIVEN PORTABLE INFUSION DEVICES |
13/30284721 DC : 0
|
BS EN ISO 8536-8 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION EQUIPMENT FOR USE WITH PRESSURE INFUSION APPARATUS |
05/30106198 DC : 0
|
EN ISO 22442-3 - MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS |
04/30118691 DC : DRAFT AUG 2004
|
BS ISO ASTM 51649 - PRACTICE FOR DOSIMETRY IN AN ELECTRON BEAM FACILITY FOR RADIATION PROCESSING AT ENERGIES BETWEEN 300 KEV AND 25 MEV |
CSA Z10651-5 : 2008 : R2013
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
02/565247 DC : DRAFT DEC 2002
|
ISO 8637 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
BS ISO 14972:1998
|
Sterile obturators for single use with over-needle peripheral intravascular catheters |
CSA Z10651-5 : 2008 : INC : UPD 1 : 2011
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
CSA Z11140.1 : 2007 : R2012
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
PREN ISO 11137-2 : DRAFT 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
CSA ISO 7199 : 0
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
CSA ISO 13488 : 1998
|
QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9002 |
AAMI ISO 11137-1:2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
ASTM F 2761 : 2009 : R2013
|
Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
BS EN ISO 11140-1:2014
|
Sterilization of health care products. Chemical indicators General requirements |
BS EN ISO 22803:2005
|
Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file |
UNE-EN ISO 16672:2016
|
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) |
EN 13503-8 : 2000
|
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS |
CEN ISO/TR 14969:2005
|
Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004) |
EN ISO 11140-1:2014
|
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
DIN EN ISO 21649:2010-01
|
Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
ASME BPE : 2016
|
BIOPROCESSING EQUIPMENT |
ANSI/AAMI/ ISO 11137-2:2013(R2019)
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
04/30078095 DC : DRAFT JUL 2004
|
ISO 11138-1 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
08/30179586 DC : DRAFT MAR 2008
|
BS ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
BS ISO 10651-5:2006
|
Lung ventilators for medical use. Particular requirements for basic safety and essential performance Gas-powered emergency resuscitators |
04/30101211 DC : DRAFT APR 2004
|
ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
14/30281560 DC : 0
|
BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES |
08/30179589 DC : DRAFT MAR 2008
|
BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS |
13/30284770 DC : 0
|
BS EN ISO 8536-9 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
03/103026 DC : DRAFT JAN 2003
|
BS EN ISO 5840 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
BS EN 60544-1:2013
|
Electrical insulating materials. Determination of the effects of ionizing radiation Radiation interaction and dosimetry |
AAMI ISO 5840 : 2005 : R2010
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
CSA Z11137-2 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
08/30179592 DC : DRAFT MAR 2008
|
BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
AAMI ISO 5840 :2005
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
CSA Z10651-5 : 2008
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
AAMI ISO 11137-2 : 2013
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
ISO/TS 15539:2000
|
Cardiovascular implants Endovascular prostheses |
ASTM F 2407 : 2006
|
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
ASTM E 1608 : 2015
|
Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for Radiation Processing at Energies between 50 keV and 7.5 MeV |
ASTM E 1538 : 2009
|
PRACTICE FOR USE OF THE ETHANOL-CHLOROBENZENE DOSIMETRY SYSTEM |
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) |
IEC 60544-1:2013
|
Electrical insulating materials - Determination of the effects of ionizing radiation - Part 1: Radiation interaction and dosimetry |
I.S. EN ISO 21649:2009
|
NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
I.S. EN ISO 11140-1:2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014) |
I.S. EN ISO 11137-2:2015
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE (ISO 11137-2:2013) |
DIN EN ISO 11137-2:2015-11
|
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
BS ISO 15572:1998
|
Guide for estimating uncertainties in dosimetry for radiation processing |
ISO 11737-3:2004
|
Sterilization of medical devices Microbiological methods Part 3: Guidance on evaluation and interpretation of bioburden data |
BS EN ISO 7197:2009
|
Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components |
AAMI ISO 10651-5 : 2006
|
LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS |
13/30284773 DC : 0
|
BS EN ISO 8536-10 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
CEI EN 60544-1 : 2014
|
ELECTRICAL INSULATING MATERIALS - DETERMINATION OF THE EFFECTS OF IONIZING RADIATION - PART 1: RADIATION INTERACTION AND DOSIMETRY |
13/30284776 DC : 0
|
BS EN ISO 8536-11 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT |
BS EN 60601-2-12:2006
|
Medical electrical equipment Particular requirements for the safety of lung ventilators. Critical care ventilators |
04/300654 DC : DRAFT JAN 2004
|
BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
BS ISO 18385:2016
|
Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements |
AAMI ISO TIR 14969 : 2004
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
02/564517 DC : DRAFT OCT 2002
|
BS EN ISO 8536-10 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
CSA ISO TR 14969 : 2005 : R2010
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
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 |
BS ISO 25539-1 : 2003
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
14/30257644 DC : 0
|
BS EN ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
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 |
04/30088722 DC : DRAFT APR 2004
|
ISO 18369-1 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 1: TERMINOLOGY |
CSA Z11137-2 : 2007 : R2012 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
CEI EN 60601-2-12 : 2007
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
ISO/TR 14969:2004
|
Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
I.S. EN ISO 7197:2009
|
NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
BS EN ISO 11137-1:2015
|
Sterilization of health care products. Radiation Requirements for development, validation and routine control of a sterilization process for medical devices |
UNE-EN ISO 11140-1:2015
|
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
ISO 7197:2006
|
Neurosurgical implants Sterile, single-use hydrocephalus shunts and components |
BS EN ISO 21649:2009
|
Needle-free injectors for medical use. Requirements and test methods |
ISO 5840:2005
|
Cardiovascular implants Cardiac valve prostheses |
ISO 22794:2007
|
Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file |
ISO 21649:2006
|
Needle-free injectors for medical use — Requirements and test methods |
04/30106146 DC : DRAFT MARCH 2004
|
BS EN 60601-1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
UNE-EN 60601-1:2008
|
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance |
UNI EN ISO 5840 : 2009
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
02/560598 DC : DRAFT FEB 2002
|
ISO/DIS 13485 - QUALITY SYSTEMS - MEDICAL DEVICES - SYSTEM REQUIREMENTS FOR REGULATORY PURPOSES |
BS EN ISO 25539-1:2017
|
Cardiovascular implants. Endovascular devices Endovascular prostheses |
UNI EN ISO 21649 : 2009
|
NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
04/30109483 DC : DRAFT AUG 2004
|
BS ISO ASTM 51608 - PRACTICE FOR DOSIMETRY IN AN X-RAY (BREMSSTRAHLUNG) FACILITY FOR RADIATION PROCESSING |
AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
01/563350 DC : DRAFT AUG 2001
|
BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
02/564513 DC : DRAFT OCT 2002
|
BS EN ISO 1135-4 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE |
04/30081258 DC : DRAFT MARCH 2004
|
BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS |
11/30219211 DC : 0
|
BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES |
BS PD ISO/TR 14969 : 2004 AMD 15958
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
03/314215 DC : DRAFT OCT 2003
|
ISO TR 14969 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
BS EN ISO 13488:2001
|
Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002 |
BS 7208-19(2001) : 2001
|
CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - VOCABULARY - PART 2: CONTACT LENS CARE PRODUCTS |
UNI EN ISO 7197 : 2009
|
NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS |
02/564516 DC : DRAFT OCT 2002
|
BS EN ISO 8536-9 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT |
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 |
07/30145258 DC : 0
|
BS ISO 20072 - AEROSOL DRUG DELIVERY DEVICES DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS |
02/565260 DC : DRAFT DEC 2002
|
ISO 8638 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
CSA ISO TR 14969 : 2005 : R2015
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
02/564518 DC : DRAFT OCT 2002
|
BS EN ISO 8536-11 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR USE WITH PRESSURE INFUSION EQUIPMENT |
09/30197784 DC : 0
|
BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
CSA Z11140.1 : 2007 : R2012 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
CSA Z11140.1 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
CSA ISO TR 14969 :2005
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
CSA ISO 11137-2 : 2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
I.S. EN 60544-1:2013
|
ELECTRICAL INSULATING MATERIALS - DETERMINATION OF THE EFFECTS OF IONIZING RADIATION - PART 1: RADIATION INTERACTION AND DOSIMETRY (IEC 60544-1:2013 (EQV)) |
I.S. EN 60601-2-12:2006
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-12: PARTICULAR REQUIREMENTS FOR THE SAFETY OF LUNG VENTILATORS - CRITICAL CARE VENTILATORS |
ISO 10651-5:2006
|
Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators |
DIN EN ISO 21649 E : 2010
|
NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
ISO 13488:1996
|
Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
UNE-EN ISO 11137-1:2015
|
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
00/565497 DC : DRAFT DEC 2000
|
BS IEC 60601-1 MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR SAFETY AND ESSENTIAL PERFORMANCE |
BS EN 13503-8:2000
|
Ophthalmic implants. Intraocular lenses Fundamental requirements |
BS EN ISO 5840:2009
|
Cardiovascular implants. Cardiac valve prostheses |
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 30-1-2:2012
|
Domestic cooking appliances burning gas. Safety Appliances having forced-convection ovens and/or grills |
EN 30-1-2:2012
|
Domestic cooking appliances burning gas - Safety - Part 1-2: Appliances having forced-convection ovens and/or grills |
EN ISO 21649:2009
|
Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
EN ISO 13488 : 2000
|
QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
EN ISO 11137-1:2015
|
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
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 ISO 7197:2009
|
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
EN ISO 11137-2:2015
|
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
01/561789 DC : DRAFT APR 2001
|
BS ISO 13960 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - PLASMAFILTERS |
ISO/TR 15844:1998
|
Sterilization of health care products Radiation sterilization Selection of sterilization dose for a single production batch |
I.S. EN ISO 11137-1:2015
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
ISO/TS 15843:2000
|
Sterilization of health care products Radiation sterilization Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits |
04/30108670 DC : DRAFT FEB 2004
|
ISO 51702 - PRACTICE FOR DOSIMETRY IN GAMMA IRRADIATION FACILITIES FOR RADIATION PROCESSING |
I.S. CEN ISO TR 14969:2005
|
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485: 2003 |
PD CEN ISO/TR 14969:2005
|
Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003 |
CSA ISO 5840 : 0
|
CARDIOVASCULAR IMPLANTS - CARIDAC VALVE PROSTHESES |
04/19975667 DC : 0
|
BS ISO 15676 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - SINGLE - USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANCE OXYGENATION |
12/30259937 DC : 0
|
BS EN 50544-1 - ELECTRICAL INSULATING MATERIALS - DETERMINATION OF THE EFFECTS OF IONIZING RADIATION - PART 1: RADIATION INTERACTION AND DOSIMETRY |
BS ISO 7197:1997
|
Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components |
11/30227618 DC : 0
|
BS ISO 11658 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS |
CSA Z11137-2 : 2007 : R2012
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
05/30060678 DC : DRAFT SEP 2005
|
BS EN ISO 22794 - DENTISTRY - IMPLANTABLE MATERIALS FOR BONE FILLING AND AUGMENTATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
ASTM F 2560 : 2006
|
Standard Specification for Supralaryngeal Airways and Connectors |
03/113382 DC : DRAFT SEP 2003
|
BS EN ISO 21649 - NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS |
ASTM F 2726 : 2008
|
Standard specification for fixation devices for tracheal tubes and other airway devices |
CSA Z10651-5 : 2008 : R2018
|
Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators |
ISO 18385:2016
|
Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements |
ISO/TS 13409:2002
|
Sterilization of health care products Radiation sterilization Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches |
DIN EN ISO 11137-1:2015-11
|
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
UNE-EN ISO 11137-2:2015
|
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
BS EN ISO 11137-2:2015
|
Sterilization of health care products. Radiation Establishing the sterilization dose |
ISO 22803:2004
|
Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file |
BS EN ISO 8320-2:2001
|
Contact lenses and contact lens care products. Vocabulary Contact lens care products |
DIN EN ISO 5840:2009-08
|
CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
EN 60544-1:2013
|
Electrical insulating materials - Determination of the effects of ionizing radiation - Part 1: Radiation interaction and dosimetry |
EN ISO 5840:2009
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Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) |
EN 60601-2-12:2006
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Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |