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SN/T 3061-2011: Rules of the inspection of packaging for import terminally sterilized medical devices
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SN/T 3061-2011	English	259	Add to Cart	3 days [Need to translate]	Rules of the inspection of packaging for import terminally sterilized medical devices

SN/T 3061-2011: Rules of the inspection of packaging for import terminally sterilized medical devices

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Rules of the inspection of packaging for import terminally sterilized medical devices People's Republic of China Entry-Exit Inspection and Quarantine Standards Imports of medical equipment sterilization packaging Laboratory Procedures Issued on. 2011-09-09 2012-04-01 implementation People's Republic of China The State Administration of Quality Supervision, Inspection and Quarantine released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Distribution of this document Institutions do not assume the responsibility to identify these patents. This standard is proposed and managed by the National Certification and Accreditation Administration Committee. This standard was drafted. People's Republic of China Beijing Entry-Exit Inspection and Quarantine Bureau. The main drafters of this standard. Leaf light, Manning, Chenqing Jun, Zhou Jun, Liu Chuan, Mary, Tangshu Tian. Imports of medical equipment sterilization packaging Laboratory Procedures

1 Scope

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.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 451.2 Paper and paperboard quantitative determination Determination of GB/T 454 paper bursting strength Determination of GB/T 455-degree tear paper and cardboard Determination of GB/T 458 air permeability of paper and cardboard GB/T 465.1 Paper and paperboard required after immersion in water bursting assay GB/T 465.2 Paper and paperboard required after immersion in water Determination of tensile strength GB/T 1540 paper and board Determination of water absorption (Cobb method) GB/T 1545.2 paper, board and pulp - Determination of pH of aqueous extracts GB/T 2678.6 paper, board and pulp - Determination of water-soluble sulfates (conductometric titration) GB/T 2828.1 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) retrieval batch inspection sampling plan GB/T 3917.1 Textiles Tear properties of fabrics - Part 1. Ballistic pendulum method Determination of tear force GB/T 4744 Textile fabrics - Determination of resistance to water penetration Hydrostatic pressure test GB/T 4745 Textile fabrics - Determination of resistance to surface wetting - Spray test GB/T 5453 Textiles - Determination of air permeability GB/T 7742.1 Textiles - Bursting properties of fabrics - Part 1. Determination of bursting strength and bursting distension hydraulic method GB/T 7974 paper, paperboard and pulp brightness (whiteness) measured diffusion/vertical method Determination of GB/T 12914 Paper and cardboard tensile strength GB 15980 standard disposable medical products GB/T 19633 Packaging for terminally sterilized medical devices Paper bags - Requirements and test methods. Part 2 SN/T 3062.2 import medical equipment sterilization packaging Sealable plastic film with a combination of breathable materials consisting of. SN/T 3062.3-2011 imports of medical equipment sterilization packaging Part 3 Bags and web requirements and test methods ISO 6588-2.2005 Paper, board and pulp - Determination of pH of aqueous extracts - Part 2. Hot Extraction ISO 9073-3 Textiles - Test methods nonwovens - Part 3. Determination of breaking strength and elongation ISO 9073-9 Textiles - Test methods nonwovens - Part 9. Determination of drape coefficient ISO 9197 Determination of paper, paperboard and pulp water-soluble chlorides Requested materials, sterile barrier systems and packaging systems. ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1 ...