Valid

SN/T 3062.1-2011Packing materials for terminally sterilized medical devices for import. Part 1: Validation requirements for forming, sealing and assembly processes (English PDF)

进口医疗器械灭菌包装 第1部分:成形 密封和装配过程的确认要求

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Issued by

General Administration of Customs

Level / Type

National · Recommended

Issue date

September 30, 2011

Implementation date

April 1, 2012

Scope

SN/T 3062.1-2011 is the English-translated version of 进口医疗器械灭菌包装 第1部分:成形 密封和装配过程的确认要求.

SN/T 3062.1-2011 — SN/T 3062 provisions of this part of the development and validation requirements for imports of medical equipment sterilization packaging process.

These processes include pre Forming a sterile barrier systems, barrier systems and packaging systems forming, sealing and assembly. This section applies to imports of medical equipment sterilization of preformed sterile barrier systems, barrier systems and packaging systems forming, sealing and assembly Confirmation.

This section does not include packaging requirements for sterile medical devices manufacturing.

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Document preview — SN/T 3062.1-2011

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 specifies the imports of medical equipment sterilization packaging process development and validation requirements. These processes include preformed sterile barrier systems, barrier systems and packaging systems forming, sealing and assembly. This standard applies to imports of medical equipment sterilization preformed sterile barrier systems, barrier systems and packaging systems for forming, sealing and assembly confirmation. This section does not include packaging of sterile medical device manufacturing requirements.

Document data

International classification (ICS): 11.040.

Chinese classification (CCS): C30.

Estimated length of the Chinese original: 11,128 words.

Adopted international standard: ISO 11607-2-2006, IDT.

Standards quoted by this document

ISO 11607-1-2006

......
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 11607

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