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SN/T 3062.1-2011 PDF English

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SN/T 3062.1-2011: Packing materials for terminally sterilized medical devices for import. Part 1: Validation requirements for forming, sealing and assembly processes
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SN/T 3062.1-2011English204 Add to Cart 3 days [Need to translate] Packing materials for terminally sterilized medical devices for import. Part 1: Validation requirements for forming, sealing and assembly processes

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Basic data

Standard ID SN/T 3062.1-2011 (SN/T3062.1-2011)
Description (Translated English) Packing materials for terminally sterilized medical devices for import. Part 1: Validation requirements for forming, sealing and assembly processes
Sector / Industry Commodity Inspection Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040
Word Count Estimation 11,128
Date of Issue 2011-09-30
Date of Implementation 2012-04-01
Quoted Standard ISO 11607-1-2006
Adopted Standard ISO 11607-2-2006, IDT
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 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.

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





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Packing materials for terminally sterilized medical devices for import.Part 1. Validation requirements for forming, sealing and assembly processes People's Republic of China Entry-Exit Inspection and Quarantine Standards Imports of medical equipment sterilization packaging Part 1. forming, sealing and The assembly process requires confirmation Part 1. Validationrequirementsforforming, sealingandassemblyprocesses (ISO 11607-2.2006, Packagingforterminalysterilizedmedicaldevices- Part 2. Validationrequirementsforforming, sealingandassemblyprocesses, IDT) 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 1. This section drafted in accordance with GB/T 1.1-2009 given rules. This section is identical with ISO 11607-2.2006 "final packaging sterilized medical devices - Part 2. forming, sealing and assembly over Confirmation process requirements "(in English). In the use of ISO 11607-2.2006 When the editorial changes, delete the ISO 11607-2.2006 in the preface, and the reference to Appendix ZA Ref. 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. Tangshu Tian, Liu Chuan, Liu Xuhui, Wenjiang, Wang Fei, Xu Min Bridge, Chenqing Jun, Li Wei. Imports of medical equipment sterilization packaging Part 1. forming, sealing and The assembly process requires confirmation

1 Scope

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.

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. ISO 11607-1.2006 final packaging sterilized medical devices - Part 1. materials, sterile barrier systems and packaging systems requirements

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Expiration date expirydate Date indicates that this date can be used, at least expressed in years. 3.2 Installation Verification instalationqualification Get device has been installed and provide evidence of their technical specifications, and the formation process of the file. [ISO /T S11139.2006] 3.3 Tag labeling Attached to a medical device or on other packaging systems for writing, printing, electronic or graphic files. Note. The label refers to identification, technical description and use of medical devices, but does not include attached files. 3.4 Action Verify operationalqualification Get device after installation by running the program when it is run within the limits of the expected evidence established, and the formation process of the file. [ISO /T S11139.2006] 3.5 Packaging systems packagingsystem Sterile barrier system and protective packaging portfolio. ...

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