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YY/T 0698.5-2023 English PDF

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US$399.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0698.5-2023: Packaging materials for terminal sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Status: Valid

YY/T 0698.5: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0698.5-2023	399	Add to Cart	4 days	Packaging materials for terminal sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods	Valid
YY/T 0698.5-2009	150	Add to Cart	Auto, < 3 mins	Packaging materials for terminal sterilized medical devices. Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods	Obsolete

Similar standards

YY/T 0698.2 YY/T 0686 YY/T 0698.4 YY/T 0698.1 YY/T 0698.3 YY/T 0698.6

Basic data

Standard ID: YY/T 0698.5-2023 (YY/T0698.5-2023)
Description (Translated English): Packaging materials for terminal sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - 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: 20,241
Date of Issue: 2023-09-05
Date of Implementation: 2024-09-15
Older Standard (superseded by this standard): YY/T 0698.5-2009
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the requirements and test methods for sealable combination bags and rolls composed of breathable materials that comply with YY/T 0698.2, 0698.3, 0698.6, 0698.7, 0698.9 or 0698.10 and plastic films that comply with Clause 4 of this document. These sealable combination bags and rolls can be used as sterile barrier systems and/or packaging systems to maintain the sterility of terminally sterilized medical devices until use. In addition to the general requirements specified in GB/T 19633.1 and GB/T 19633.2, this standard specifies specific requirements and test methods for the materials covered by this part. This document applies only to packaging materials for single-use terminally sterilized medical devices.

YY/T 0698.5-2023: Packaging materials for terminal sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - 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.
ICS 11.080.040 CCSC31 Pharmaceutical Industry Standards of the People's Republic of China Replace YY/T 0698.5-2009 Terminal sterilization medical device packaging materials Part 5.Breathable materials and plastic films Requirements and test methods for sealable combination bags and rolls Published on 2023-09-05 Implemented on 2024-09-15 Released by the State Drug Administration

Preface III Introduction IV 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 1 4 Requirements 2 4.1 General 2 4.2 Material 2 4.3 Structure and Design 2 4.4 Process indicators 3 4.5 Performance requirements and test methods 3 4.6 Identification 3 5 Information provided by the manufacturer4 Appendix A (normative) Determination method of resistance to expected sterilization process 5 A.1 Preparation of specimen 5 A.2 Step 5 A.3 Test report 5 Appendix B (Normative) Determination method for pinholes in plastic films 6 B.1 Instruments and Reagents 6 B.2 Preparation of test pieces 6 B.3 Step 6 B.4 Test report 6 Appendix C (Normative) Method for determination of strength of sealing joint between combination bag and roll material 7 C.1 Principle 7 C.2 Test method 7 C.3 Test Preparation---Sampling Instructions 7 C.4 Step 7 C.5 Test report 8 Appendix D (Normative) Method for determination of peel properties of paper/plastic combination products 9 D.1 Equipment 9 D.2 Procedure 9 D.3 Test report 9 Appendix E (normative) Fiber direction determination method 10 E.1 Instrument 10 E.2 Step 10 E.3 Test report10 Reference 11

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document is Part 5 of YY/T 0698 "Packaging Materials for Terminal Sterilization Medical Devices". YY/T 0698 has released the following part. ---Part 1.Requirements and test methods for co-extruded plastic films for blister packaging; ---Part 2.Sterilization packaging material requirements and test methods; ---Part 3.Paper requirements for the production of paper bags (specified in YY/T 0698.4), combination bags and rolls (specified in YY/T 0698.5) and test methods; ---Part 4.Paper bag requirements and test methods; ---Part 5.Requirements and test methods for sealable combination bags and rolls composed of breathable materials and plastic films; ---Part 6.Requirements and test methods for paper production of sterile barrier systems used in low-temperature sterilization processes or radiation sterilization; ---Part 7.Requirements and test methods for sealable gummed paper used in the production of ethylene oxide or radiation sterilized sterile barrier systems; ---Part 8.Requirements and test methods for reusable sterilization containers for steam sterilizers; ---Part 9.Material requirements and test methods for unglued polyolefin nonwovens used in the production of sealable combination bags, rolls and covers; ---Part 10.Material requirements and test methods for rubberized polyolefin nonwovens used in the production of sealable combination bags, rolls and covers. This document replaces YY/T 0698.5-2009 "Terminal Sterilization Medical Device Packaging Materials Part 5.Breathable Materials and Plastic Film Groups" "Requirements and test methods for sealable combination bags and rolls", compared with YY/T 0698.5-2009, except for structural adjustments and editorial changes In addition, the main technical changes are as follows. a) Changed the “scope” (see Chapter 1, Chapter 1 of the.2009 edition); b) The term “medical institution” is deleted (see 3.1 of the.2009 version); c) "4.2.1 Breathable Materials" adds the content "Breathable materials should comply with the requirements of YY/T 0698 Part 2" (see 4.2.1); d) Added requirements for peeling characteristics and peeling direction to minimize fiber damage (see 4.5.2 and 4.5.3); e) Changed some contents of "4.6.1 Combination bags and rolls" and "4.6.2 Transport and/or storage packaging" (see 4.6.1, 4.6.2, 2009 version 4.6.1, 4.6.2); f) Changed the content of the method for measuring the strength of the sealed connection between the combination bag and the roll material, and added an illustration of the sealing example (see Appendix C, Appendix C of the.2009 edition); g) Added the method for measuring the peeling characteristics of paper/plastic combination products (see Appendix D); h) Added fiber direction determination method (see Appendix E). Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Equipment (SAC/TC106). This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, DuPont (China) R&D Management Co., Ltd., Shanghai Construction China Medical Device Packaging Co., Ltd., Shandong Xinhua Medical Device Co., Ltd., and Zhejiang Kindly Medical Device Co., Ltd. The main drafters of this document. Wang Dongwei, Qian Jun, Wang Youqiong, Han Xingwei, Zhang Bo, Chen Fang, Zhang Qian.

Introduction

The general title of the GB/T 19633 series of standards is "Terminal Sterilization Medical Device Packaging" and consists of two parts. Part 1 of the standard series Preformed sterile barrier systems, sterile barrier systems and packaging systems intended to maintain the sterility of terminally sterilized medical devices until use General requirements and test methods, Part 2 specifies the validation requirements for forming, sealing and assembly processes. GB/T 19633.1 provides general requirements for packaging of terminally sterilized medical devices. The YY/T 0698 series of standards can be used to confirm compliance with one or more requirements specified in GB/T 19633.YY/T 0698 is intended to regulate Fanhe promotes the development and progress of this type of industry and plans to consist of the following parts. ---Part 1.Requirements and test methods for co-extruded plastic films for blister packaging; ---Part 2.Sterilization packaging material requirements and test methods; ---Part 3.Paper requirements for the production of paper bags (specified in YY/T 0698.4), combination bags and rolls (specified in YY/T 0698.5) Sum test method; ---Part 4.Paper bag requirements and test methods; ---Part 5.Requirements and test methods for sealable combination bags and rolls composed of breathable materials and plastic films; ---Part 6.Requirements and test methods for paper production of sterile barrier systems used in low-temperature sterilization processes or radiation sterilization; ---Part 7.Requirements and test methods for sealable gummed paper used in the production of ethylene oxide or radiation sterilized sterile barrier systems; ---Part 8.Requirements and test methods for reusable sterilization containers for steam sterilizers; ---Part 9.Material requirements and test methods for unglued polyolefin nonwovens used in the production of sealable combination bags, rolls and covers; ---Part 10.Material requirements and test methods for rubberized polyolefin nonwovens used in the production of sealable combination bags, rolls and covers. Terminal sterilization medical device packaging materials Part 5.Breathable materials and plastic films Requirements and test methods for sealable combination bags and rolls

1 Scope

This document specifies the breathable materials complying with YY/T 0698.2, 0698.3, 0698.6, 0698.7, 0698.9 or 0698.10 and complying with this document Requirements and test methods for sealable combination bags and rolls composed of plastic films specified in Chapter 4 of this document. These sealable combination bags and rolls are available Create a sterile barrier system and/or packaging system to ensure the sterility of terminally sterilized medical devices until use. In addition to the general requirements specified in GB/T 19633.1 and GB/T 19633.2, this document specifies specific requirements for the materials covered by this section. Sum test method. This document applies only to packaging materials for single-use terminally sterilized medical devices.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB/T 7408 Data elements and exchange format information exchange date and time representation GB 18282.1 Chemical indicators for sterilization of health care products Part 1.General principles GB/T 19633.1 Packaging of terminally sterilized medical devices Part 1.Requirements for materials, sterile barrier systems and packaging systems YY/T 0681.2 Test methods for sterile medical device packaging Part 2.Sealing strength of soft barrier materials YY/T 0698.2 Packaging materials for terminally sterilized medical devices Part 2.Requirements and test methods for sterilization packaging materials YY/T 0698.3 Packaging materials for terminally sterilized medical devices Part 3.Paper bags (specified in YY/T 0698.4), combination bags and rolls Material (YY/T 0698.5 specified) paper production requirements and test methods YY/T 0698.6 Packaging materials for terminally sterilized medical devices Part 6.Sterile screens for low-temperature sterilization processes or radiation sterilization Paper requirements and test methods for barrier system production YY/T 0698.7 Packaging materials for terminally sterilized medical devices Part 7.Production of sterile barrier systems for ethylene oxide or radiation sterilization Requirements and test methods for sealable gummed paper for production use YY/T 0698.9 Packaging materials for terminally sterilized medical devices Part 9.Glue-free production of sealable combination bags, rolls and covers Material requirements and test methods for polyolefin nonwovens YY/T 0698.10 Packaging materials for terminally sterilized medical devices Part 10.Glue for the production of sealable combination bags, rolls and covers Material requirements and test methods for polyolefin nonwovens

3 Terms and definitions

The terms and definitions defined in GB/T 19633.1 apply to this document. ......

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Question 1: How long will the true-PDF of YY/T 0698.5-2023_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0698.5-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0698.5-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0698.5-2023_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version YY/T 0698.5-2023?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0698.5-2023 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.