AAMI ISO 11607-1 : 2006 : R2010
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
14/30255135 DC : 0
|
BS EN ISO 11607-1:2009/A1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
12/30261215 DC : 0
|
BS EN 13060 - SMALL STEAM STERILIZERS |
11/30252448 DC : 0
|
BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
PREN 14180 : DRAFT 2012
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
17/30351717 DC : 0
|
BS EN ISO 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
CSA Z17665-2 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
AAMI ISO 17665-1 : 2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
PREN 13060 : DRAFT 2012
|
SMALL STEAM STERILIZERS |
AAMI ISO 11607-1 : 2006
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
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 |
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) |
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) |
CSA Z17665-1 : 2009 : FR
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
UNE-EN ISO 11607-1:2017
|
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014) |
DIN EN 1422:2014-08
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
BS EN ISO 14534:2015
|
Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements |
DIN EN 1422:1997-11
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
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) |
PREN 1422 : DRAFT 2011
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
12/30262894 DC : 0
|
BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
PD CEN ISO/TS 16775:2014
|
Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
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 |
DIN EN ISO 11607-2:2014-11
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014) |
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 |
04/30048205 DC : DRAFT JUL 2004
|
BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
UNI CEN ISO/TS 17665-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
I.S. EN ISO 11607-2:2017 & LC:2017
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006, INCLUDING AMD 1:2014) |
AAMI ISO TIR 17665-2 : 2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
AAMI ISO 11607-2:2006
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES |
CSA Z17665-2:09 (R2019)
|
Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT) |
DIN EN ISO 17665-1:2006-11
|
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
I.S. EN ISO 14534:2015
|
OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011) |
I.S. EN 14180:2014
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
I.S. EN 1422:2014
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
DIN EN 14180:2003-10
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
I.S. EN ISO 17665-1:2006
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
DIN EN ISO 11607-1:2014-11
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014) |
17/30351720 DC : 0
|
BS EN ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
09/30207531 DC : 0
|
BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS |
AAMI ISO 11607-2 : 2006 : R2010
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES |
ANSI/AAMI ISO 17665-1:2006(R2013)
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
CSA Z17665-1 : 2009 : R2014
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
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 |
BS EN ISO 11607-1:2017
|
Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems |
UNI EN 14180 : 2014
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
UNI EN 1422 : 2014
|
STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
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 |
CSA ISO 11607-1 : 2016
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
PREN 17180 : DRAFT 2017
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING |
ISO 11607-2:2006
|
Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
CSA ISO 11607-2 : 2016
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
ANSI/AAMI/ISO TIR16775:2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
AAMI/ISO TIR17665-2:2009(R2016)
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1 |
I.S. EN ISO 11607-1:2017
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006, INCLUDING AMD 1:2014) |
PREN 868-4 : DRAFT 2015
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS |
BS EN ISO 11607-1 : 2009
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
UNE-EN ISO 11607-2:2017
|
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014) |
UNI EN ISO 11607-1 : 2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS |
ISO 11607-1:2006
|
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
BS EN ISO 11607-1:2020
|
Packaging for terminally sterilized medical devices Requirements for materials, sterile barrier systems and packaging systems |
DIN EN 14180:2014-09
|
STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
DIN EN ISO 14534:2015-08
|
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
BS EN 554:1994
|
Sterilization of medical devices. Validation and routine control of sterilization by moist heat |
ISO/TS 16775:2014
|
Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
BS EN ISO 17665-1:2006
|
Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
ISO 17665-1:2006
|
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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) |
BS EN 14180:2014
|
Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing |
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 1422:2014
|
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
EN ISO 14534:2015
|
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011) |
EN 14180:2014
|
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
EN ISO 17665-1 : 2006
|
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
02/124462 DC : DRAFT DEC 2002
|
BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
CSA Z17665-2:09 (R2019)
|
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15) |
DD CEN ISO/TS 17665-2:2009
|
Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1 |
S.R. CEN ISO/TS 17665-2:2009
|
STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1 |
15/30325861 DC : 0
|
BS EN 868-4 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS |
14/30255138 DC : 0
|
BS EN ISO 11607-2:2006/A1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
ANSI/AAMI/ISO 11607-1:2006/(R)2015
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS, AND PACKAGING SYSTEMS |
15/30325858 DC : 0
|
BS EN 868-6 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS |
BS EN ISO 11607-2 : 2006
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
04/30101215 DC : DRAFT APR 2004
|
ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
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 |
CSA Z17665-1:09 (R2019)
|
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations) |
UNI EN ISO 11607-2 : 2014
|
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES |
BS EN 1422:2014
|
Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods |
ISO/TS 17665-2:2009
|
Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
CEN ISO/TS 17665-2:2009
|
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009) |