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SN/T 3062.2-2011 PDF English

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SN/T 3062.2-2011: Packaging materials for terminally sterilized medical devices for import. Part 2: Paper bags. Requirements and test methods
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SN/T 3062.2-2011English209 Add to Cart 3 days [Need to translate] Packaging materials for terminally sterilized medical devices for import. Part 2: Paper bags. Requirements and test methods

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Basic data

Standard ID SN/T 3062.2-2011 (SN/T3062.2-2011)
Description (Translated English) Packaging materials for terminally sterilized medical devices for import. Part 2: Paper bags. Requirements and test methods
Sector / Industry Commodity Inspection Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040
Word Count Estimation 8,876
Date of Issue 2011-09-09
Date of Implementation 2012-04-01
Quoted Standard EN 868-3; ISO 1924-2; ISO 6588-2-2005; ISO 8601; ISO 9197; ISO 9198; ISO 11140-1; ISO 11607-1-2006
Adopted Standard BS EN 868-4-2009, MOD
Regulation (derived from) National Quality Inspection (2011) 492; industry standard filing Notice 2012 No. 4 (No. 148 overall)
Issuing agency(ies) General Administration of Customs
Summary This standard provides for the import and export of medical devices Requirements and test methods paper, its purpose is to protect the terminally sterilized medical devices sterile requirements. Under this Part for imports of medical equipment sterilization paper bags only for the sole purpose of packaging.

SN/T 3062.2-2011: Packaging materials for terminally sterilized medical devices for import. Part 2: Paper bags. Requirements and test methods





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Packaging materials for terminally sterilized medical devices for import.Part 2. Paper bags.Requirements and test methods People's Republic of China Entry-Exit Inspection and Quarantine Standards Imports of medical equipment sterilization packaging Part 2. Requirements and test methods for paper bags Part 2. Paperbags-Requirementsandtestmethods (BSEN868-4.2009, Packagingmaterialsfor Requirementsandtestmethods, MOD) 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

SN/T 3062 "import medical equipment sterilization packaging" is divided into four parts. --- Part 1. forming, sealing and assembly processes to confirm the request; --- Part 2. Paper bags - Requirements and test methods; --- Part 3. sealable bags and coil combination requirements and test methods breathable material and plastic film composition; --- Part 4. Materials and preformed sterile barrier system requirements. This section SN/T 3062 Part 2. This section drafted in accordance with GB/T 1.1-2009 given rules. The partial modification using BSEN868-4.2009 "sterile medical device packaging materials - Part 4. Paper bags - Requirements and determination method". This portion BSEN868-4. compared to 2009, made the following changes. --- Modify the standard structure, format, chapter is structured; --- Modify the normative references; --- Deleted Appendix A "to this European standard and the previous version of the major technological changes more"; --- BSEN868-4.2009 in Appendix B and Appendix C of this standard as Appendix A and Appendix B. This section proposed and managed by the National Certification and Accreditation Administration Committee. This section was drafted by. People's Republic of China Beijing Entry-Exit Inspection and Quarantine Bureau. The main drafters of this section. Fan Fei, Yao Zhenyu Zhou Jun, Liu Xuhui, Li Guoqing, Tangshu Tian, Chenqing Jun. Imports of medical equipment sterilization packaging Part 2. Requirements and test methods for paper bags

1 Scope

SN/T 3062 This section specifies the requirements and test methods for paper bags imported medical devices, and its purpose is to protect the final sterilization Sterile medical equipment requirements. This Part of the paper used for imports of medical equipment sterilization packaging applies only to unique applications.

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. Packaging materials and systems - Part 3 EN868-3 medical sterilization items. Sterilization of medical devices and systems for the production of packaging materials Paper bag with paper (see detailed provisions EN868-4) and production of pouches and reels of paper requirements and test methods (see EN868-5 detailed provisions) Constant rate extension method. Part 2 ISO 1924-2 Determination of tensile properties of paper and board ISO 6588-2.2005 Determination of pH paper, paperboard and pulp water extraction Characterization data exchange format information and times ISO 8601 Data and Information Exchange ISO 9197 Determination of paper, paperboard and pulp water-soluble chlorides ISO 9198 Determination of paper, paperboard and pulp water soluble sulphates ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1. General requirements ISO 11607-1.2006 final packaging sterilized medical devices - Part 1. materials, sterile barrier systems and packaging systems requirements

3 Terms and Definitions

ISO 11607-1.2006 definition of terms and definitions apply to this document.

4 General requirements

4.1 General See ISO 11607-1.2006 requirements. Forming process validation requirements, sealing, assembly process, see ISO 11607-2. NOTE. ISO 11607-1.2006 5.1.4 refers to the production and processing conditions influence (for electrostatic conductivity, bioburden) for its products. 4.2 Structure and Design 4.2.1 General 4.2.1.1 paper should be unified according to EN868-3 specified by the manufacturer. 4.2.1.2 The following terms shall be described in a paper bag design. a) the back. paper bags have a longitudinal seam side; b) front. no bags longitudinal seam side; ...

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