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ISO 10993-7:2008

Действует
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals — 94 стр.
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Ссылочные документы

ISO 10993-7:2008/Cor.1:2009
Действует
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals -- Technical Corrigendum 1 — 2 стр.

На этот документ ссылаются

ISO 10993-7:2008/Cor.1:2009
Действует
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals -- Technical Corrigendum 1 — 2 стр.
BS EN ISO 16061:2009
Заменен
Instrumentation for use in association with non-active surgical implants. General requirements — 28 стр.
17/30357741 DC
Действует
BS ISO 11040-6. Prefilled syringes. Part 6. Plastic barrels for injectables and sterilized subassembled syringes ready for filling — 63 стр.
BS EN ISO 16671:2015
Заменен
Ophthalmic implants. Irrigating solutions for ophthalmic surgery — 32 стр.
BS EN ISO 8637:2014
Действует
Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators — 34 стр.
BS EN ISO 7198:2017
Действует
Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches — 68 стр.
BS EN ISO 12417-1:2015
Действует
Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products. General requirements — 64 стр.
BS EN ISO 11135:2014
Действует
Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices — 94 стр.
BS EN ISO 10993-17:2009
Действует
Biological evaluation of medical devices. Establishment of allowable limits for leachable substances — 36 стр.
BS EN 12022:1999
Действует
Blood-gas exchangers — 12 стр.
BS EN 1422:2014
Действует
Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods — 54 стр.
BS ISO 18385:2016
Действует
Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements — 30 стр.
BS ISO 18746:2016
Действует
Traditional Chinese medicine. Sterile intradermal acupuncture needles for single use — 20 стр.
BS ISO 18562-4:2017
Действует
Biocompatibility evaluation of breathing gas pathways in healthcare applications. Tests for leachables in condensate — 18 стр.
BS ISO 17218:2014
Действует
Sterile acupuncture needles for single use — 36 стр.
BS ISO 15676:2016
Действует
Cardiovascular implants and artificial organs. Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) — 20 стр.
BS ISO 11658:2012
Действует
Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems — 14 стр.
PD ISO/TR 37137:2014
Действует
Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants — 26 стр.
PD ISO/TR 15499:2016
Действует
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process — 24 стр.
18/30349202 DC
Действует
BS ISO 21881. Sterile packaged ready for filling cartridges — 29 стр.
BS EN ISO 10451:2010
Действует
Dentistry. Contents of technical file for dental implant systems — 16 стр.
BS EN ISO 22803:2005
Действует
Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file — 16 стр.
BS ISO 11712:2009
Действует
Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors — 1 стр.
18/30349205 DC
Действует
BS ISO 21882. Sterile packaged ready for filling vials — 24 стр.
BS EN ISO 7199:2017
Действует
Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) — 28 стр.
BS EN ISO 16061:2015
Действует
Instrumentation for use in association with non-active surgical implants. General requirements — 28 стр.
BS EN ISO 22794:2009
Действует
Dentistry. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery. Contents of a technical file — 20 стр.
PD CEN ISO/TS 16775:2014
Действует
Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 — 124 стр.
BS ISO 15675:2016
Действует
Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters — 16 стр.
BS ISO 15674:2016
Действует
Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags — 18 стр.
BS ISO 8637-3:2018
Действует
Extracorporeal systems for blood purification. Plasmafilters — 22 стр.
BS ISO 20698:2018
Действует
Catheter systems for neuraxial application. Sterile and single-use catheters and accessories — 28 стр.
BS ISO 18241:2016
Действует
Cardiovascular implants and extracorporeal systems. Cardiopulmonary bypass systems. Venous bubble traps — 18 стр.
BS ISO 11040-4:2015
Действует
Prefilled syringes. Glass barrels for injectables and sterilized subassembled syringes ready for filling — 62 стр.
18/30375452 DC
Действует
BS EN ISO 22442-1. Medical devices utilizing animal tissues and their derivatives. Part 1. Application of risk management — 35 стр.
BS EN ISO 22442-1:2015
Действует
Medical devices utilizing animal tissues and their derivatives. Application of risk management — 38 стр.
BS EN ISO 10993-1:October 2009
Действует
Biological evaluation of medical devices. Evaluation and testing within a risk management process — 32 стр.
BS EN ISO 14630:2012
Действует
Non-active surgical implants. General requirements — 24 стр.
BS EN ISO 8637-2:2018
Действует
Extracorporeal systems for blood purification. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters — 22 стр.
BS EN ISO 8638:2014
Заменен
Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters — 24 стр.
BS ISO 27427:2013
Действует
Anaesthetic and respiratory equipment. Nebulizing systems and components — 58 стр.
BS EN ISO 7405:2008+A1:2013
Действует
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry — 44 стр.
BS EN ISO 16671:2015+A1:2017
Действует
Ophthalmic implants. Irrigating solutions for ophthalmic surgery — 32 стр.
BS ISO 18242:2016
Действует
Cardiovascular implants and extracorporeal systems. Centrifugal blood pumps — 20 стр.
ÖNORM EN ISO 11135:2014-10
Заменен
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
ÖNORM EN ISO 11135-1:2007-08
Заменен
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
ÖNORM EN ISO 11135:2015-03
Заменен
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
ÖNORM EN ISO 7199:2014-12
Заменен
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)
ÖNORM EN ISO 8638:2014-03
Заменен
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
ÖNORM EN ISO 25539-1:2011-03
Заменен
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005) (consolidated version)
ÖVE/ÖNORM EN 60601-1:2014-02
Действует
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) (english version)