SN/T 3062.3-2011Packaging materials for terminally sterilized medical devices for import. Part 3: Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods (English PDF)
进口医疗器械灭菌包装 第3部分：透气材料与塑料膜组成的可密封组合袋和卷材要求和试验方法
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Issued by
General Administration of Customs
Level / Type
National · Recommended
Issue date
September 9, 2011
Implementation date
April 1, 2012
Scope
SN/T 3062.3-2011 is the English-translated version of 进口医疗器械灭菌包装 第3部分：透气材料与塑料膜组成的可密封组合袋和卷材要求和试验方法.
SN/T 3062.3-2011 — SN/T 3062 provisions of this part of the packaging used for sterilization of medical devices sealed bags and sheets - Test methods and requirements.
The main purpose of this section is to establish appropriate standards for the sterile barrier system or packaging to ensure sterility of the sterilization of medical devices.
Note 1. The packaging is required pollution by manufacturers and consumers to decide. All devices are specified in this part-time use. Note 2.
When additional materials used within the sterile barrier system in order to achieve another purpose, such as to improve the organization, drying or disinfection (such as. corrosion within the band, filters, indicating , A packing list, inner liner, brochures, tray mats or medical devices outside the additional package), will implement additional requirements include whether these materials it can be used in the verification activities and the like.
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Document preview — SN/T 3062.3-2011
National Standard of the People's Republic of China
- ICS
- 11.040
- Classification
- C 30
Issued by: General Administration of Customs
Contents
- What this standard covers1
- Document data2
- Standards quoted by this document3
What this standard covers
This standard provides for sterile medical device packaging sealed bags and roll test methods and requirements. The main purpose of this section is to establish a sterile barrier system or packaging to ensure that appropriate standards sterilized medical devices sterile. This standard specifies that all devices are disposable.
Document data
International classification (ICS): 11.040.
Chinese classification (CCS): C30.
Estimated length of the Chinese original: 10,158 words.
Adopted international standard: BS EN 868-5-2009, IDT.
Standards quoted by this document
ASTM D882-1995; EN 868-2; EN 868-3; EN 868-6; EN 868-7; EN 868-9; EN 868-10; EN ISO 11140-1; EN ISO 11607-1-2006; ISO 8601
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 7 pages — is available in the English PDF.
Referenced standards
Normative references
ISO 11140 · ISO 11607 · ISO 8601
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Related Standards
SN/T 3062.1-2011 — Packing materials for terminally sterilized medical devices for import. Part 1: Validation requirements for forming, sealing and assembly processes
SN/T 3062.2-2011 — Packaging materials for terminally sterilized medical devices for import. Part 2: Paper bags. Requirements and test methods
SN/T 3062.4-2011 — Packaging materials for terminally sterilized medical devices for import. Part 4: Requirements for materials and sterile barrier systems of importing medical device sterilization packaging
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SN/T 3062.3-2011
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