CSA Z15882 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
DIN EN ISO 8638:2014-03
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
BS EN ISO 8638:2014
|
Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
PREN 285 : DRAFT 2013
|
STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
DIN EN ISO 8638 E : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
BS EN ISO 6710:2017
|
Single-use containers for human venous blood specimen collection |
AAMI ISO 11140-4 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION |
CSA ISO 8637 : 2012
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
CSA ISO 8637 : 2012 : R2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
AAMI/ISO TIR17665-3:2014(R2016)
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
S.R. CEN ISO/TS 16775:2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014) |
CAN/CSA-ISO/TS 16775:17
|
Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15) |
UNI EN ISO 13408-6 : 2013
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
EN 285:2015
|
Sterilization - Steam sterilizers - Large sterilizers |
EN ISO 8536-4:2013/A1:2013
|
INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013) |
DIN EN ISO 11140-1:2015-03
|
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
ISO 8637:2010
|
Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
BS EN ISO 11140-1:2014
|
Sterilization of health care products. Chemical indicators General requirements |
ISO 8638:2010
|
Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
ISO 11140-1:2014
|
Sterilization of health care products Chemical indicators Part 1: General requirements |
EN ISO 8638:2014
|
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010) |
EN ISO 11140-1:2014
|
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
CEN ISO/TS 16775:2014
|
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014) |
I.S. EN ISO 6710:2017
|
SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO 6710:2017) |
PD CEN ISO/TS 16775:2014
|
Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
DIN EN ISO 13408-6:2013-07
|
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013) |
PD ISO/TS 17665-3:2013
|
Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
13/30278676 DC : 0
|
BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
AAMI ISO 11140-5 : 2007
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS |
AAMI ISO 11140-4 : 2007 : R2012
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION |
ISO 19979:2018
|
Ophthalmic optics — Contact lenses — Hygienic management of multipatient use trial contact lenses |
CSA ISO 8638 : 2012 : R2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
ISO 8637-1:2017
|
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
ANSI/AAMI/ISO TIR16775:2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
ISO 5910:2018
|
Cardiovascular implants and extracorporeal systems Cardiac valve repair devices |
AAMI ISO 8638 : 2010
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
BS EN ISO 13408-6 : 2011
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
AAMI ISO 8638 : 2010 : R2015
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS |
ISO 18362:2016
|
Manufacture of cell-based health care products Control of microbial risks during processing |
I.S. EN ISO 13408-6:2011
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005) |
EN ISO 6710:2017
|
Single-use containers for human venous blood specimen collection (ISO 6710:2017) |
DIN EN 556-2:2015-11
|
STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
BS EN 556-2:2015
|
Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices |
ISO 13408-6:2005
|
Aseptic processing of health care products Part 6: Isolator systems |
I.S. EN ISO 17510-1:2009
|
SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
I.S. EN ISO 11140-1:2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11140-1:2014) |
EN ISO 17510-1:2009
|
Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
I.S. EN 285:2015
|
STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
16/30348158 DC : 0
|
BS EN ISO 6710 - SINGLE-USE CONTAINERS FOR VENOUS BLOOD SPECIMEN COLLECTION |
DIN EN ISO 8637 E : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01) |
AAMI ISO 15882 : 2008
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
BS EN ISO 8637:2014
|
Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
CSA Z15882:09 (R2019)
|
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (Adopted ISO 15882:2008, second edition, 2008-09-01) |
AAMI ISO 11140-5 : 2007 : R2012
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS |
AAMI ISO 13408-6 : 2005 : INC : AMD 1 : 2013
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
I.S. EN ISO 8637:2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01) |
I.S. EN ISO 8638:2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010) |
UNI EN ISO 8637 : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
ISO/TS 17665-3:2013
|
Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization |
ISO 6710:2017
|
Single-use containers for human venous blood specimen collection |
DIN EN 285:2016-05
|
Sterilization - Steam sterilizers - Large sterilizers |
UNE-EN ISO 11140-1:2015
|
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
UNI EN ISO 8536-4 : 2013
|
INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED |
UNI EN ISO 15882 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
DIN EN ISO 8637:2014-03
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1:2013-04-01) |
16/30331656 DC : 0
|
BS ISO 8637-3 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 3: PLASMAFILTERS |
I.S. EN 556-2:2015
|
STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
AAMI ISO 8637 : 2010
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS |
CSA Z15882 :2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
EN ISO 13408-6:2011/A1:2013
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS (ISO 13408-6:2005/AMD 1:2013) |
16/30280931 DC : DRAFT APR 2016
|
BS EN ISO 17664 - PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
16/30331653 DC : 0
|
BS EN ISO 8637-2 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 2: EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
AAMI ISO 13408-6:2005
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
ANSI/AAMI/ISO 13408-6:2005(R2013)&A1:2013
|
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 6: ISOLATOR SYSTEMS |
UNI EN ISO 8638 : 2014
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
I.S. EN ISO 25539-1:2017
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
UNI EN ISO 17510-1 : 2009
|
SLEEP APNOEA BREATHING THERAPY - PART 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT |
EN ISO 8637:2014
|
Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01) |
I.S. EN ISO 8536-4:2013
|
INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010) |
DIN EN ISO 8536-4:2013-07
|
INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010 + AMD 1:2013) |
BS EN ISO 17510-1:2009
|
Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment |
UNE-EN 556-2:2016
|
Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
ISO/TS 16775:2014
|
Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
ANSI/AAMI/ISO 15882:2008(R2013)
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS |
BS EN 285:2015
|
Sterilization. Steam sterilizers. Large sterilizers |
ISO 8536-4:2010
|
Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed |
BS EN ISO 15882:2008
|
Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results |
UNI CEN ISO/TS 16775 : 2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
EN 556-2:2015
|
Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
EN ISO 15882:2008
|
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008) |
16/30331650 DC : 0
|
BS EN ISO 8637-1 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
BS ISO 18362:2016
|
Manufacture of cell-based health care products. Control of microbial risks during processing |
17/30326683 DC : DRAFT SEP 2017
|
BS ISO 19979 - OPHTHALMIC OPTICS - CONTACT LENSES - HYGIENIC MANAGEMENT OF MULTIPATIENT USE TRIAL CONTACT LENSES |
CSA ISO 8638 : 2012
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS |
CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 : R2017
|
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS |
AAMI ISO TIR 17665-3:2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION |
BS ISO 19979:2018
|
Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses |
CSA ISO 11140-1 : 2016
|
STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
UNE-EN 285:2016
|
Sterilization - Steam sterilizers - Large sterilizers |
ISO 15882:2008
|
Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
ISO 17510-1:2007
|
Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment |