11.080.30 消毒封装 标准查询与下载
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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems; Amendment 1
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2014-07
- 实施
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006/Amd 1:2014)
- ICS
- 11.080.30
- CCS
- 发布
- 2014-07
- 实施
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)
- ICS
- 11.080.30
- CCS
- 发布
- 2014-07
- 实施
Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 2014-05-31
- 实施
- 2014-05-31
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
- ICS
- 11.080.30
- CCS
- A84
- 发布
- 2014-05-01
- 实施
Diese Technische Spezifikation enthalt Leitlinien fur die Anwendung der in ISO 11607-1 und ISO 11607-2 enthaltenen Anforderungen. Durch das vorliegende Dokument werden die Anforderungen von ISO 11607-1 und/oder ISO 11607-2 weder erganzt noch verandert. Dies ist ein informatives, kein normatives Dokument. Das vorliegende Dokument enthalt keine Anforderungen, die als Grundlage fur regulatorische Uberwachungen oder fur Ablaufe der Zertifizierungsbewertung zu verwenden sind. Dieser Leitfaden kann verwendet werden, um die Anforderungen von ISO 11607-1 und/oder ISO 11607-2 besser zu verstehen und um einige der zahlreichen Verfahren und Ansatze, die zur Erfullung der Anforderungen von ISO 11607-1 und/oder ISO 11607-2 zur Verfugung stehen, zu veranschaulichen. Es ist nicht erforderlich, das vorliegende Dokument zum Nachweis der Einhaltung Internationaler Normen anzuwenden. Dieses Dokument enthalt Leitlinien zur Bewertung, Auswahl und Verwendung von Verpackungsmaterialien, vorgefertigten Sterilbarrieresystemen, Sterilbarrieresystemen und Verpackungssystemen. Es enthalt auserdem Hinweise zu den Validierungsanforderungen an Prozesse der Formgebung, Siegelung und der Zusammenstellung. Dieses Dokument enthalt Informationen fur Einrichtungen des Gesundheitswesens (siehe Abschnitt 3) und fur die Medizinprodukteindustrie (siehe Abschnitt 4). Dieses Dokument enthalt keine Leitlinien fur die Verwendung von Verpackungsmaterialien und Verpackungssystemen nach dem Offnen. Fur die Verwendung von Verpackungen fur andere Zwecke, wie z. B. als "steriles Feld" oder den Transport kontaminierter Artikel, sind andere regulatorische Standards anwendbar.
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
- ICS
- 11.080.30
- CCS
- 发布
- 2014-05
- 实施
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2014-05
- 实施
Sterilization - Transport baskets for sterile barrier systems - Part 2: Sterilizing baskets made of metal
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 2012-04
- 实施
Sterilization - Transport baskets for sterile barrier systems - Part 3: Instrument trays for sterilizing goods made of metal
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 2012-04
- 实施
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
- ICS
- 11.080.30
- CCS
- 发布
- 2011-04
- 实施
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management
- ICS
- 11.080.30
- CCS
- 发布
- 2011-04
- 实施
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled sterile
- ICS
- 11.080.30
- CCS
- C04
- 发布
- 2011-01-01
- 实施
Packaging for terminally sterilized medical devices. General requirements
- ICS
- 11.080.30
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants
- ICS
- 11.080.30
- CCS
- 发布
- 2011
- 实施
- 2013-01-01
Sterilization - Sterile supply - Part 9: Use of sterilization container
- ICS
- 11.080.30
- CCS
- C48
- 发布
- 2010-05
- 实施
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
- ICS
- 11.080.30
- CCS
- C05
- 发布
- 2010-05
- 实施
Sterilization - Sterile supply - Part 8: Logistics of sterile medical devices
- ICS
- 11.080.30
- CCS
- C05
- 发布
- 2010-05
- 实施
Sterilization - Sterile supply - Part 7: Use of sterilization paper, nonwoven wrapping material, textile materials, paper bags and sealable pouches and reels
- ICS
- 11.080.30
- CCS
- C48
- 发布
- 2010-05
- 实施
Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
- ICS
- 11.080.30
- CCS
- 发布
- 2010-02-28
- 实施
- 2010-02-28
This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 2010-02-28
- 实施
- 2010-02-28
