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YY/T 0698.10-2009 English PDF

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US$194.00 · In stock
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YY/T 0698.10-2009: Packaging materials for terminally sterilized medical devices. Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids. Requirements and test methods
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0698.10-2009	194	Add to Cart	3 days	Packaging materials for terminally sterilized medical devices. Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids. Requirements and test methods	Valid

Similar standards

YY/T 0698.2 YY/T 0686 YY/T 0698.4 YY/T 0698.5 YY/T 0698.1 YY/T 0698.6

Basic data

Standard ID: YY/T 0698.10-2009 (YY/T0698.10-2009)
Description (Translated English): Packaging materials for terminally sterilized medical devices. Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids. 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: 10,155
Date of Issue: 2009-06-16
Date of Implementation: 2010-12-01
Quoted Standard: GB/T 451.2; GB/T 451.3; GB/T 454; GB/T 455; GB/T 458; GB/T 4744; GB/T 12914; ISO 6588-2-2005; ISO 11607-1; ASTM D 2724
Adopted Standard: prEN 868-10-2007, IDT
Regulation (derived from): Industry standard filing Notice 2009 No. 9
Issuing agency(ies): State Food and Drug Administration
Summary: This standard provides for terminally sterilized medical devices packaging adhesive polyolefin nonwoven material requirements and test methods. This part is not on ISO 11607-1 General requirements increased requirements. Thus, 4. 2 to 4. 3 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. Provisions of this section are expected to part or all of the material used in combination sealable bag forming Fill Seal (FFS) packaging and packaging timber lid production.

YY/T 0698.10-2009: Packaging materials for terminally sterilized medical devices. Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids. 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 terminally sterilized medical devices.Part 10. Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids.Requirements and test methods ICS 11.080.040 C31 People's Republic of China pharmaceutical industry standards Terminally sterilized medical devices packaging materials Part 10. sealable bags combination, and the web Cover material production adhesive polyolefin nonwovens Requirements and test methods Posted 2009-06-16 2010-12-01 implementation State Food and Drug Administration issued

Foreword

YY/T 0698 "terminally sterilized medical device packaging materials," consists of the following components. --- 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. sealable bags and coil combination requirements and test methods breathable material and plastic film composition; --- Part 6. Requirements and test methods for the production of paper sterile barrier system or low temperature sterilization processes for radiation sterilization; --- Part 7. ethylene oxide or radiation sterilization production sealable adhesive paper requirements and test methods for sterile barrier system; --- 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 Part of 100,698. Requirements and test methods other terminally sterilized medical devices packaging material will be covered in other sections. YY/T 0698 with reference to the use of this part of prEN868-10.2007 "terminally sterilized medical devices - Part 10 packing material. Seals Bags, and the cover sheet material production nonwovens requirements and test methods "by gluing polyolefins. This section of the Appendices A and B are normative appendix. This part of the National Standardization Technical Committee appliances medical infusion made. This part of the jurisdiction of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. This part mainly drafted by. Shandong Province Medical Devices Product Quality Inspection Center, DuPont China Holdings Limited. The main drafters of this section. Qian Jun, Wu Ping.

Introduction

ISO 116071) standard the general title "Packaging for terminally sterilized medical devices", consists of two parts. Part 1 of this standard specifies Expected before use to keep terminally sterilized medical devices to common sterile preformed sterile barrier systems, sterile barrier systems and packaging systems Sum test methods. Part 2 of this standard specifies validation requirements forming, sealing and assembly processes. Each sterile barrier system must meet the requirements of ISO 11607-1. YY/T 0698 standard can be used to demonstrate compliance with one or more of the requirements specified in ISO 11607-1. 1) EN868-1.1997 has been ISO 11607-1.2006 is replaced. Our correspondence with the ISO 11607 standard is GB/T 19633-2005 (ISO 11607.2003, IDT). Please note that the revision of GB/T 19633 of. Terminally sterilized medical devices packaging materials Part 10. sealable bags combination, and the web Cover material production adhesive polyolefin nonwovens Requirements and test methods

1 Scope

YY/T 0698 This section provides the requirements apply to terminally sterilized medical devices packaging adhesive polyolefin material and non-woven fabric experiment method. This part is not general requirements for ISO 11607-1 requirements increase. Thus, in the 4.2 to 4.3 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. This Part of the material is expected to be used for part or all of seal assembly bag forming - fill - seal (FFS) packaging and lidding material produce.

2 Normative references

The following documents contain provisions which, through reference YY/T 0698 and become part of the provisions of this section. For dated references, All subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the agreement on this section Whether the parties can study the latest versions of these documents. For undated reference documents, the latest versions apply to this section. GB/T 451.2 Paper and paperboard quantitative determination (GB/T 451.2-2002, eqv ISO 536.1995) GB/T 451.3 Paper and board - Determination of thickness (GB/T 451.3-2002, idt ISO 534. 1988) GB/T 454 Determination of bursting strength of paper (GB/T 454-2002, idt ISO 2758.2001) GB/T 455 Paper and board - Determination of tearing resistance (GB/T 455-2002, eqv ISO 1974.1990) GB/T 458 Paper and board - Determination of air permeability (GB/T 458-2008, ISO 5636-2. 1984, ISO 5636-3.1992, ISO 5636-5.2003, MOD) GB/T 4744 Textile fabrics - Determination of resistance to water penetration Hydrostatic pressure test (GB/T 4744-1997, eqv ISO 811. 1981) GB/T 12914 Paper and board - Determination of tensile strength (GB/T 12914-2008, eqv ISO 1924-2.1994, MOD) ISO 6588-2.2005 Paper, board and pulp - Determination of pH of aqueous extracts - Part 2. Hot Extraction Requested materials, sterile barrier systems and packaging systems. ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1 ASTMD2724 paste layer, heat seal layer and test methods for composite fabric clothing

3 Terms and Definitions

Terms and definitions apply to the establishment of ISO 11607-1 YY/T 0698 to the present section.

4 Requirements

4.1 General ISO 11607-1 apply. NOTE. The following specific requirements and test methods can be used to demonstrate compliance with ISO 11607-1 one or more of the requirements, but not all of the requirements. 4.2 Material 4.2.1 After the adhesive material should be translucent or opaque substrate made of high purity continuous polyolefin fibers together, should not be released with sufficient Substances to health risks. Note. See GB/T 16886.1. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0698.10-2009_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0698.10-2009_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0698.10-2009_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0698.10-2009_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.