JIS T 9301:2016 単回使用ごうしん（毫鍼） | ページ 6

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T 9301 : 2016
                                          附属書D
                                          (参考)
                                          参考文献
[1] ISO 780:1997,Packaging−Pictorial marking for handling of goods
[2] ISO 2859-1:1999,Sampling procedures for inspection by attributes−Part 1: Sampling schemes indexed by
    acceptance quality limit (AQL)   or lot-by-lot inspection
[3] ISO 3696:1987,Water for analytical laboratory use−Specification and test methods
[4] ISO 6507-2:2005,Metallic materials−Vickers hardness test−Part 2: Verification and calibration of testing
    machines
[5] ISO 6507-3:2005,Metallic materials−Vickers hardness test−Part 3: Calibration of reference blocks
[6] ISO 7864:1993,Sterile hypodermic needles for single use
[7] ISO 7000:2012,Graphical symbols for use on equipment−Registered symbols
[8] ISO 9626:1991,Stainless steel needle tubing for the manufacture of medical devices (Amendment 1 published
    2001)
[9] ISO 10282:2002,Single-use sterile rubber surgical gloves−Specification
[10] ISO 10993-1:2009,Biological evaluation of medical devices−Part 1: Evaluation and testing within a risk
    management process
[11] ISO 10993-5:2009,Biological evaluation of medical devices−Part 5: Tests for in vitro cytotoxicity
[12] ISO 10993-7:2008,Biological evaluation of medical devices−Part 7: Ethylene oxide sterilization residuals
[13] ISO 10993-10:2010,Biological evaluation of medical devices−Part 10: Tests for irritation and skin
    sensitization
[14] ISO 10993-11:2006,Biological evaluation of medical devices−Part 11: Tests for systemic toxicity
[15] ISO 11135-1:2007,Sterilization of health care products−Ethylene oxide−Part 1: Requirements for
    development, validation and routine control of a sterilization process for medical devices
[16] ISO 11137-1:2006,Sterilization of health care products−Radiation−Part 1: Requirements for development,
    validation and routine control of a sterilization process for medical devices
[17] ISO 11137-2:2013,Sterilization of health care products−Radiation−Part 2: Establishing the sterilization dose
[18] ISO 11138-1:2006,Sterilization of health care products−Biological indicators−Part 1: General requirements
[19] ISO 11138-2:2006,Sterilization of health care products−Biological indicators−Part 2: Biological indicators
    for ethylene oxide sterilization processes
[20] ISO 11607-1:2006,Packaging for terminally sterilized medical devices−Part 1: Requirements for materials,
    sterile barrier systems and packaging systems
[21] ISO 11607-2:2006,Packaging for terminally sterilized medical devices−Part 2: Validation requirements for
    forming, sealing and assembly processes
[22] ISO 11737-1:2006,Sterilization of medical devices−Microbiological methods−Part 1: Determination of a
    population of microorganisms on products
[23] ISO 11737-2:2009,Sterilization of medical devices−Microbiological methods−Part 2: Tests of sterility
    performed in the definition, validation and maintenance of a sterilization process

――――― [JIS T 9301 pdf 26] ―――――

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                                                                                   T 9301 : 2016
[24] ISO 13485:2003,Medical devices−Quality management systems−Requirements for regulatory purposes
[25] ISO 14971:2007,Medical devices−Application of risk management to medical devices
[26] ISO 15223-1:2012,Medical devices−Symbols to be used with medical device labels, labelling and information
    to be supplied−Part 1: General requirements
[27] ISO 15223-2:2010,Medical devices−Symbols to be used with medical device labels, labelling, and
    information to be supplied−Part 2: Symbol development, selection and validation
[28] ISO 15510:2010,Stainless steels−Chemical composition
[29] ISO 17665-1:2006,Sterilization of health care products−Moist heat−Part 1: Requirements for the
    development,validation and routine control of a sterilization process for medical devices
[30] EN 980:2008,Graphical symbols for use in the labelling of medical devices
[31] EN 1041:2008,Information supplied by the manufacturer of medical devices
[32] EN 10088-1:2005,Stainless steels. List of stainless steels
[33] WFAS STANDARD-001:2012,Acupuncture needles
[34] GB/T 1031-1995,Surface roughness parameters and their values
[35] GB 2024-1994,Acupuncture needles
[36] GB/DRT 2024-2010,Acupuncture needles (Draft standard)
[37] KS P 3007:2009,Sterile disposable acupuncture needle
[38] YY 0043-2005,Medical suture needle
[39] YY/T 0149-2006,Medical instruments of stainless steel−Test methods of corrosive resistance
[40] YY 0666-2008,Method for the test of sharpness and strength of needles tips
[41] 93/42/EEC,Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
[42] 2007/47/EC,Directive of the European Parliament and of the Council of 5 September 2007 amending Council
    Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable
    medical devices,Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning
    the placing of biocidal products on the market

――――― [JIS T 9301 pdf 27] ―――――

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                                         附属書JA
                                          (規定)
                                    金しん(鍼)材料
JA.1 概要
  この附属書は,金しん(鍼)の線材について規定する。
JA.2 金しん(鍼)線材
  線材は金,銀,銅及び亜鉛で構成され,主成分である金の含有量によって表JA.1の三つに分類する。
                                   表JA.1−金しん(鍼)線材
                   規格名称                            成分
                金しん(鍼)A    金91100 %,銀09 %,銅09 %,亜鉛09 %
                 金しん(鍼)B   金8190 %,銀019 %,銅019 %,亜鉛019 %
                 金しん(鍼)C   金7180 %,銀029 %,銅029 %,亜鉛029 %
JA.3 材折り曲げ試験
  材折り曲げ試験は,図JA.1のように線材を保持し,次のとおり矢印の方向へ折り曲げる。
− (1回目)90度折り曲げ
− (2回目)180度反対に折り返す
− (3回目)180度反対側に戻す
  試験は,被検査ロットから折り曲げ試験試料10本をサンプリングし,次のとおり実施する。
                            図JA.1−金しん(鍼)線材折り曲げ試験法
JA.4 検査
  この試験は使用線径規格ごとに実施するものとし,判定基準は次のとおりとする。
  サンプル10本中7本以上が,3回以上の折り曲げに耐えて,切断しない。

――――― [JIS T 9301 pdf 28] ―――――

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                                                                                   T 9301 : 2016
JA.5 線径の許容差
  線径の公称線径に対する許容差は,表JA.2による。
                                     表JA.2−線径の許容差
                                                                    単位 mm
                               線径                         許容差
                                   0.10以下                 ±0.005
                        0.10を超え 0.20以下                 ±0.006
                        0.20を超え 0.40以下                 ±0.008
                        0.40を超えるもの                    ±0.010

――――― [JIS T 9301 pdf 29] ―――――

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                                         附属書JB
                                          (規定)
                                    銀しん(鍼)材料
JB.1   概要
  この附属書は,銀しん(鍼)の線材について規定する。
JB.2   銀しん(鍼)線材
  線材は,銀・銅・亜鉛・ニッケルで構成され,主成分である銀の含有量によって表JB.1の四つに分類す
る。
                                   表JB.1−銀しん(鍼)線材
                 規格名称                              成分
              銀しん(鍼)A   銀91100 %,銅09 %,亜鉛09 %,ニッケル00.5 %
              銀しん(鍼)B   銀8190 %,銅019 %,亜鉛019 %,ニッケル00.5 %
              銀しん(鍼)C   銀7180 %,銅029 %,亜鉛029 %,ニッケル00.5 %
              銀しん(鍼)D   銀6170 %,銅039 %,亜鉛039 %,ニッケル00.5 %
JB.3   材折り曲げ試験
  材折り曲げ試験は,図JB.1のように線材を保持し,次のとおり矢印の方向へ折り曲げる。
− (1回目)90度折り曲げ
− (2回目)180度反対に折り返す
− (3回目)180度反対側に戻す
  試験は,被検査ロットから折り曲げ試験試料10本をサンプリングし,次のとおり実施する。
                            図JB.1−銀しん(鍼)線材折り曲げ試験法
JB.4   検査
  この試験は使用線径規格ごとに実施するものとし,判定基準は次のとおりとする。
  サンプル10本中7本以上が,3回以上の折り曲げに耐えて,切断しない。

――――― [JIS T 9301 pdf 30] ―――――

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