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YY 0585.3-2018 (YY 0585.3-2005) PDF English

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YY 0585.3-2005: Fluid lines for use with pressure infusion equipment and accessories for single use - Part 3: Filters
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Status: Obsolete

YY 0585.3: Historical versions

Standard IDUSDBUY PDFDeliveryStandard Title (Description)Status
YY 0585.3-2018199 Add to Cart 3 days Fluid lines for use with pressure infusion equipment and accessories for single use. Part 3: Filters Valid
YY 0585.3-200590 Add to Cart Auto, 9 seconds. Fluid lines for use with pressure infusion equipment and accessories for single use - Part 3: Filters Obsolete

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YY 0585.4   YY 0585.2   YY 0585.1   YY/T 0581.2   

YY 0585.3-2005: Fluid lines for use with pressure infusion equipment and accessories for single use - Part 3: Filters


---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0585.3-2005
YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.20 C 31 YY 0585.3-2005 / ISO 8536-11.2004 Fluid lines for use with pressure infusion equipment and accessories for single use – Part 3.Filters (ISO 8536-11.2004, Infusion equipment for medical use – Part 11.Infusion filters for use with pressure infusion equipment, IDT) Issued on: DECEMBER 7, 2005 Implemented on: DECEMBER 1, 2006 Issued by. China Food and Drug Administration

Table of Contents

Foreword... 3 1 Scope... 4 2 Normative references... 4 3 Designation... 4 4 Design... 4 5 Materials... 5 6 Physical requirements... 5 7 Chemical requirements... 5 8 Biological requirements... 5 9 Packaging... 6 10 Labelling... 6 Annex A (Normative) Physical tests... 8 Annex B (Normative) Chemical tests... 10 Annex C (Normative) Biological tests... 11 Bibliography... 12 Fluid lines for use with pressure infusion equipment and accessories for single use - Part 3.Filters

1 Scope

This Part of YY 0585 applies to sterilized infusion filters for single use up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in YY 0286.4.It does not include the effectiveness of filters for separation of particles or germs.

2 Normative references

The articles contained in the following documents have become part of this Part of YY 0585 when they are quoted herein. For the dated documents so quoted, all the modifications (excluding corrections) or revisions made thereafter shall not be applicable to this Part. For the undated documents so quoted, the latest editions shall be applicable to this Part. GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2.Lock fittings (GB/T 1962.2-2001, idt ISO 594-2.1994) GB 8368 Infusion sets for single use, gravity feed (GB 8368-2005, ISO 8536-4.2004, MOD) YY 0286.4 Special infusion sets - Part 4.Single-use infusion equipment for use with pressure infusion apparatus (YY 0286.4-2006, ISO 8536-8.2004, IDT) YY 0466 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied (YY 0466-2003, ISO 15223.2000, IDT)

3 Designation

Designation of an infusion filter (IF) for infusions under pressure (P). Infusion filter YY 0585.3-IF-P

4 Design

The infusion filter housing shall be provided with a venting system to anticipate the blocking of the filter by the accumulation of air bubbles. Bibliography [1] GB/T 16886.4 Biological evaluation of medical devices - Part 4.Selection of tests for interactions with blood (GB/T 16886.4-2003, ISO 10993-4, IDT) [2] GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use - Part 2.Biological test methods [3] GB 18278-2000 Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization (idt ISO 11134.1994) [4] GB 18279-2000 Medical devices - Validation and routine control of ethylene oxide sterilization (idt ISO 11135.1994) [5] GB 18280-2000 Sterilization of health care products - Requirements for validation and routine (idt ISO 11137.1995) [6] GB/T 6682-1992 Water for analytical laboratory use - Specification and test methods (neq ISO 3696.1997) [7] Chinese Pharmacopoeia [8] ISO 31-3 Quantities and units - Part 3.Mechanics ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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