YY/T 0698.1-2011 English PDF

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YY/T 0698.1-2011: Packaging materials for terminal sterilized medical devices. Part 1: Co-extrusion plastic films used for vacuum forming packaging. Requirements and test methods
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0698.1-2011	169	Add to Cart	3 days	Packaging materials for terminal sterilized medical devices. Part 1: Co-extrusion plastic films used for vacuum forming packaging. Requirements and test methods	Valid

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Basic data

Standard ID: YY/T 0698.1-2011 (YY/T0698.1-2011)
Description (Translated English): Packaging materials for terminal sterilized medical devices. Part 1: Co-extrusion plastic films used for vacuum forming packaging. Requirements and test methods
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C31
Classification of International Standard: 11.080.040
Word Count Estimation: 7,745
Date of Issue: 2011-12-31
Date of Implementation: 2013-06-01
Quoted Standard: GB/T 458-2008; GB/T 6672; GB/T 6673; GB/T 7408; GB/T 8809; GB/T 16578.1; GB/T 1040.1; GB/T 1040.2; GB/T 1040.3; GB/T 1040.4; GB/T 1040.5
Regulation (derived from): State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the terminally sterilized medical devices packaging plastic packaging co-extruded plastic film (hereinafter referred to as "plastic film") requirements and test methods. This standard applies to medical device for blister packaging for medical devices coextruded plastic film. This part is not general requirements for ISO 11607-1 requirements increase, so that 4. 2 to 4. 5 in the special requirements of ISO 11607-1 can be used to demonstrate compliance with one or more of the requirements, but not all of its requirements. By a plastic film and other packaging materials composed of medical equipment sterile barrier system, which enables users to see the contents before opening the package to facilitate aseptic technique.

YY/T 0698.1-2011: Packaging materials for terminal sterilized medical devices. Part 1: Co-extrusion plastic films used for vacuum forming packaging. Requirements and test methods

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Packaging materials for terminal sterilized medical devices.Part 1. Co-extrusion plastic films used for vacuum forming packaging.Requirements and test methods ICS 11.080.040 C31 People's Republic of China pharmaceutical industry standards Terminally sterilized medical devices packaging materials Part 1. plastic packaging co-extruded plastic film Requirements and test methods Part 1. Co-extrusionplasticfilmsusedforvacuumformingpackaging- Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

Foreword

YY/T 0698 "terminally sterilized medical device packaging materials," including the following sections. Co-extruded plastic film plastic packaging requirements and test methods;. --- Part 1 --- Part 2. Sterilization wrap material requirements and test methods; --- Part 3. paper (YY/T 0698.4 forth), a combination of bags and coils (YY/T 0698.5 forth) to produce paper Sum Test methods; --- Part 4. Paper bags - Requirements and test methods; --- Part 5. ziplock and roll and sealing requirements and test methods for paper and plastic film in combination; --- Part 6. Paper for low temperature sterilized production requirements and test methods for the sterile barrier system procedures or radiation sterilization; --- Part 7. ethylene oxide for medical or radiation sterilization sealable sterile barrier systems used in the production of paper coating requirements and tests method; --- Part 8. steam sterilizers repeatability requirements and test methods for sterilizing containers; --- Part 9. combination sealable bags, and the cover sheet material production without nonwovens requirements and test methods for coating polyolefin; --- Part 10. combination sealable bags, and the cover sheet material production nonwovens requirements and test methods for coating polyolefin; This section YY/T Section 10698 of. This section drafted in accordance with GB/T 1.1-2009 given rules. Requirements and test methods other medical device packaging will be specified in the YY/T 0698 in other parts. Appendix A of this standard is a normative appendix. This part is proposed by the State Food and Drug Administration. This part of the National medical infusion apparatus of Standards and Technology Committee (SAC/TC106) centralized. This part mainly drafted by. Fuzhou Green Packaging Materials Co. sails. Participated in the drafting of this section. Sealed Air Packaging (China) Co., Ltd. This part drafters. Liwen Xu, Zhang Haijun, bility, Zhang.

Introduction

ISO 116071 series of standards under the general title "Packaging for terminally sterilized medical devices", consists of two parts. Part 1 of the series of standards Which provides, expected before use to keep terminally sterilized medical devices sterile preformed sterile barrier systems, sterile barrier systems and packaging systems General requirements and test methods. Part 2 of the series of standards specifies validation requirements forming, sealing and assembly processes. Each sterile barrier system must meet the requirements of ISO 11607-1. YY/T 0698 series of standards can be used to demonstrate compliance with one or more of the requirements specified in ISO 11607-1. When a standard setting, ISO 11607 series of standards being converted to our standards. The future of the corresponding standard is GB/T 19633 series of standards. Terminally sterilized medical devices packaging materials Part 1. plastic packaging co-extruded plastic film Requirements and test methods

1 Scope

YY/T 0698 provisions of this part of the terminally sterilized medical devices packaging plastic packaging co-extruded plastic film (hereinafter referred to as "plastic film") Requirements and test methods. This standard applies to the co-extruded plastic film instrumentarija medical equipment for plastic packaging. This part is not general requirements for ISO 11607-1 requirements increase, so that in the 4.2 to 4.5 can be used to demonstrate compliance with special requirements One or more of the requirements of ISO 11607-1, but not all of its requirements. The plastic film and other packaging materials medical equipment sterile barrier system, which enables the user before opening the package to see the contents, in order to In aseptic.

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. Determination of GB/T 458-2008 air permeability of paper and cardboard Determination of GB/T 1040 (all parts) Tensile Properties of Plastics GB/T 6672 plastic film and sheeting - Determination of thickness by mechanical scanning Determination of GB/T 6673 plastic film and sheet length and width GB/T 7408 Data elements and interchange formats - Information interchange the date and time notation GB/T 8809 plastic film anti-pendulum impact test GB/T Determination of plastic film and sheet tear resistance of 16578.1 - Part 1. Trouser tear method

3 Terms and Definitions

Terms and definitions defined in ISO 11607-1 apply to this document.

4 Requirements

4.1 General ISO 11607-1 The requirements apply. 4.2 Material Plastic film should be co-extruded composite made by the two or more layers. 4.3 Specifications Plastic film thicknesses should be selected within the range of 0.06mm ~ 0.2mm. NOTE. Expected plastic molding packaging should choose darker thicker plastic film, packing some special equipment may require more than 0.2mm plastic film. ......

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