GOST ISO 11607-2011
ГОСТ ISO 11607-2011
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Packaging for terminally sterilized medical devices. General requirements
Упаковка для медицинских изделий, подлежащих финишной стерилизации. Общие требования
Status: Not effective - Superseded. Registration information 546-st dated 08/30/2018 (official website of Rosstandart); IUS 11-2018
This standard establishes the requirements for disposable materials and reusable containers used for packaging medical devices subjected to finishing sterilization, carried out both in industry and in health care institutions. This standard establishes the basic requirements for the development and validation of the packaging process for the manufacturer of medical products subjected to finishing sterilization
Настоящий стандарт устанавливает требования к одноразовым материалам и многоразовым контейнерам, используемым для упаковывания медицинских изделий, подвергаемых финишной стерилизации, проведенного как в промышленности, так и в учреждениях здравоохранения Настоящий стандарт устанавливает основные требования к разработке и валидации процесса упаковывания для производителя медицинских изделий, подвергаемых финишной стерилизации
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
12/13/2011
SKU: RUSS71856
The Product is Contained in the Following Classifiers:
ISO classifier »
11 HEALTH »
11.080 Sterilization and disinfection »
National standards »
11 HEALTH »
11.080 Sterilization and disinfection »
ISO classifier »
11 HEALTH »
11.080 Sterilization and disinfection »
11.080.01 Sterilization and disinfection in general »
National standards »
11 HEALTH »
11.080 Sterilization and disinfection »
11.080.01 Sterilization and disinfection in general »
National Standards for KGS (State Standards Classification) »
Latest edition »
R Health. Sanitation and hygiene items »
R2 Equipment and tools of medical institutions »
R26 Apparatus, accessories and equipment used for sterilization, distillation, disinfection and disinsection »
The Document is Replaced With:
GOST ISO 11607-1-2018: Packaging for medical devices subject to terminal sterilization. Part 1. Requirements for materials, sterilization barrier systems and packaging systems
The Document References:
GOST 30114-95: Paper and board. Determination of air permeance (medium range). General requirements for methods
GOST ISO 11140-1-2011: Sterilization of health care products. Chemical indicators. Part 1. General requirements
GOST ISO 9001-2011: Quality management systems. Requirements
The Document is Referenced By:
GOST 31620-2012: Surgical sutures. General technical requirements. Test method
GOST 32314-2012: Factory made mineral wool products used for thermal insulation of buildings. General specifications
GOST ISO 11140-1-2011: Sterilization of health care products. Chemical indicators. Part 1. General requirements
GOST ISO 8836-2012: Suction catheters for use in the respiratory tract
GOST R 55038-2012: Ophthalmic optics. Ophthalmic implants. Ocular endotamponades. General safety requirements
GOST R 58551-2019: Medical disposable products from nonwoven materials. Clothes and surgical disposable non-woven fabrics. Technical Requirements for Public Procurement
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