I.S. EN ISO 22523:2006
|
EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
01/563350 DC : DRAFT AUG 2001
|
BS ISO 25539-1 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
03/304741 DC : DRAFT APR 2003
|
IEC 60601-1-6 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - USABILITY |
CR 14060:2000
|
Medical device traceability |
CSA ISO 7199 : 0
|
CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
BS EN 556-1:2001
|
Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Part 1. Requirements for terminally sterilized medical devices |
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 |
BS EN ISO 22523:2006
|
External limb prostheses and external orthoses. Requirements and test methods |
CR 12401 : 1996
|
DENTISTRY - GUIDANCE ON THE CLASSIFICATION OF DENTAL DEVICES AND ACCESSORIES |
EN ISO 22523 : 2006
|
EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006) |
08/30179586 DC : DRAFT MAR 2008
|
BS ISO 7199 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
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 |
BS ISO 8009-1:1997
|
Reusable rubber contraceptive diaphragms Classification, sampling and requirements |
08/30179592 DC : DRAFT MAR 2008
|
BS ISO 15675 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
AAMI ST72 : 2011 : R2016
|
BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING |
ISO/TS 15539:2000
|
Cardiovascular implants Endovascular prostheses |
I.S. EN 556-1:2002
|
STERILISATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED STERILE - PART 1: REQUIREMENTS FOR TERMINALLY STERILISED MEDICAL DEVICES |
03/317861 DC : DRAFT OCT 2003
|
EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS |
BS ISO 25539-1 : 2003
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
AAMI ST72 : 2011
|
BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING |
DIN EN ISO 22523:2007-04
|
External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) |
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 |
01/561789 DC : DRAFT APR 2001
|
BS ISO 13960 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - PLASMAFILTERS |
BS ISO 8009:2014
|
Mechanical contraceptives. Reusable natural and silicone rubber contraceptive diaphragms. Requirements and tests |
05/30106194 DC : 0
|
EN ISO 22442-2 - MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
ISO 13683:1997
|
Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities |
PD CEN/TR 15253:2005
|
Health informatics. Quality of service requirements for health information interchange |
ISO 8009:2014
|
Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests |
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 |
ISO 22523:2006
|
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 |
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 |
99/562423 DC : DRAFT APR 99
|
BS:ENISO 14937 - STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL CRITERIA FOR CHARACTERIZATION OF A STERILIZING AGENT AND DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS |
CEN/TR 15253 : 2005
|
HEALTH INFORMATICS - QUALITY OF SERVICE REQUIREMENTS FOR HEALTH INFORMATION INTERCHANGE |
14/30281557 DC : 0
|
BS EN ISO 7198 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES |
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 |
11/30227618 DC : 0
|
BS ISO 11658 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS |
S.R. CR 14060:2000
|
MEDICAL DEVICE TRACEABILITY |
PD CR 12401:2003
|
Dentistry. Guidance on the classification of dental devices and accessories |
DIN EN 13795-1:2009-10
|
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 |