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SN/T 3061-2011Rules of the inspection of packaging for import terminally sterilized medical devices (English PDF)

进口医疗器械灭菌包装检验操作规程

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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 3061-2011 is the English-translated version of 进口医疗器械灭菌包装检验操作规程.

SN/T 3061-2011 — This standard specifies the direct contact with imported medical device sterilization packaging containers, packaging material inspection mode selection, sampling, test methods, Inspection rules, principles and judged unqualified disposal.

This standard applies to direct contact with imported medical equipment sterilization packaging containers, packaging materials inspection, the body does not apply to medical devices.

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Document preview — SN/T 3061-2011

National Standard of the People's Republic of China

ICS: 11.040
Classification: C 30

Issued by: General Administration of Customs

What this standard covers1
Document data2
Standards quoted by this document3

What this standard covers

This standard specifies the direct contact with the medical device sterilization of imported packaging containers, packaging materials testing mode selection, sampling, test methods, inspection rules, determine the principles and unqualified disposal. This standard applies to direct contact with imported medical equipment sterilization packaging containers, packaging materials inspection, the body does not apply to medical devices.

Document data

International classification (ICS): 11.040.

Chinese classification (CCS): C30.

Estimated length of the Chinese original: 10,187 words.

Standards quoted by this document

GB/T 451.2; GB/T 454; GB/T 455; GB/T 458; GB/T 465.1; GB/T 465.2; GB/T 1540; GB/T 1545.2; GB/T 2678.6; GB/T 2828.1; GB/T 3917.1; GB/T 4744; GB/T 4745; GB/T 5453; GB/T 7742.1; GB/T 7974; GB/T 12914; GB 15980; GB/T 19633; SN/T 3062.2; SN/T 3062.3-2011; ISO 6588-2-2005; ISO 9073-3; ISO 9073-9; ISO 9197; ISO 11607-1; EN 1149-1

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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

GB/T 1545.2 · GB/T 19633 · ISO 6588 · ISO 9073 · ISO 9197 · ISO 11607

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