標準編號:	GB 15810-2019
中文名稱:	一次性使用無菌注射器
英文名稱:	Sterile syringes for single use
中標分類:	C31    一般與顯微外科器械
行業分類:	GB    國家標準
ICS分類:	11.040.20 11.040.20    輸血、輸液和注射設備 11.040.20
發布機構:	國家市場監督管理總局 國家標準化管理委員會
發布日期:	2019-10-14
實施日期:	2020-11-1
標準狀態:	valid
替代舊標準:	GB 15810-2001 一次性使用無菌注射器
翻譯語言:	英文
文件格式:	PDF
中文字符數:	29000 字
翻譯價格(元):	560.0
交付時間:	付款后 1 個工作日

Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative. All technical contents of this standard are mandatory. This standard is developed in accordance with the rules given in GB/T 1.1-2009. This standard replaces GB 15810-2001 Sterile hypodermic syringes for single use. The following main technical changes have been made with respect to GB 15810-2001 (the previous edition): ——The clause “Scope” is modified (see Clause 1; Clause 1 of Edition 2001); ——The definitions of "two-piece syringe", "three-piece syringe", "dead space", "piston", "barrel flanges", "needle cap or shield" and "plunger" are added (see 3.6, 3.7, 3.11, 3.12, 3.13 and 3.14); ——The Figure 1 and its name are modified (see Figure 1; Figure 1 of Edition 2001); ——The requirements for lubricating oil are modified (see 5.1.4; 5.1.4 of Edition 2001); ——The requirements for “spacing of push-button” is modified (see 5.5.1; 5.5.1 of Edition 2001); ——The requirements "rubber plunger stoppers shall be free of rubber threads, rubber crumbs, foreign impurities and frost spray, and shall conform to those specified in YY/T 0243, and plunger stoppers made of other materials shall conform to those specified in corresponding standards" are deleted (5.8.1 of Edition 2001); ——The “fit of piston in barrel” is added (see 5.7.4); ——The requirement “syringes shall be pyrogen free" is deleted (see 5.12.2 of Edition 2001); ——The requirement “hemolysis: syringe has no hemolysis reaction" is deleted (see 5.12.3 of Edition 2001); ——The requirement "acute systemic toxicity: syringe shall have no acute systemic toxicity" is deleted (see 5.12.4 of Edition 2001); ——“Test method” is deleted (see Clause 6 of Edition 2001); ——The requirements for "primary packaging" are modified, and the requirements for primary packaging materials and needle packaging forms are added (see 8.1; 7.1 of Edition 2001); ——The “Structural changes of this standard with respect to ISO 7886-1: 2017” is added (see Annex A); ——The “Test method for capacity tolerance and residual capacity” is added (see Annex B); ——The “Test method for liquid leakage of syringe at piston or seal(s) under positive compression” is added (see Annex C); ——The “Test method for leakage past piston or seal(s) during aspiration, and for separation of piston and plunger” is added (see Annex D); ——The “Test method for sliding performance” is modified (see Annex E); ——The “Test method for fitting between syringe barrel and piston” is added (see Annex F); ——The “Preparation of extracts and test method” is added (see Annex G); ——The “biological evaluation” and “material guide” are combined into “Guidelines for design and materials”, which is modified (see Annex H; Annexes D and E of Edition 2001); ——The “hemolysis test” is deleted (see Annex B of Edition 2001); ——The “inspection rules” is deleted (see Annex C of Edition 2001); This standard is revised by redrafting ISO 7886-1: 2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use. This standard is changed largely from ISO 7886-1: 2017 in structure; the comparison table for clause numbers in this standard and those in ISO 7886-1：2017 are listed in Annex A. The technical differences with respect to ISO 7886-1: 2017 and the reasons are as follows: ——The adjustments of technical deviations are made for the normative references in this standard so as to adapt to the technical conditions of China. The specific adjustment is reflected in Clause 2 "Normative reference", with the specific adjustments as follows: ? YY/T 0466.1 identical to the international standard is used to replace ISO 15223-1: 2016; ? ISO 23908 is deleted; ? ISO 80369-7 is deleted; ? GB/T 1962.1 is added for reference (see 5.6.1); ? GB/T 1962.2 is added for reference (see 5.6.1); ? GB/T 6682 is added for reference (see B.1.2.3, B.2.2.2, C.2.4, E.2.4, F.2, G.1.2.1 and G.2); ? GB/T 14233.1-2018 is added for reference (see 6.3 and G.2); ? GB/T 14233.2 is added for reference (see 7.3); ? YY/T 0466.1 is added for reference (see 9.1); ——The requirement of "Scope" is modified, deleting the requirement that syringes without needles be used together with sterile injection needles for single use. ——The unit packaging, user packaging, self-contained syringe units and multiple unit pack in "Terms and definitions" are deleted; ——The requirements for "appearance" are modified, and the expression of test conditions is adjusted; ——The design requirements and lubricant requirements are incorporated into Annex H (informative) "Guidelines for design and materials" and modified; ——The requirements for readily oxidizable substances (see 6.3) and residual ethylene oxide (see 6.4) in chemical requirements are added; ——The requirements for sterility (see 7.2) and bacterial endotoxin (see 7.3) in biological requirements are added; ——The requirements of 8.1 “primary packaging" are modified, and the requirements that air-permeable packaging materials and needle packaging forms be used for primary packaging are added. ——The “Test method for capacity tolerance and residual capacity” is added (see Annex B); ——The “Test method for fitting between syringe barrel and piston” is added (see Annex F); ——The “pH/extractable metal content/preparation of extract of easily oxidized substances” is modified (see G.1); ——The “Test method for ethylene oxide residue” is added (see G.2); ——The “Test method for the quantity of silicone” is deleted (see Annex F of ISO 7886-1: 2007). The following editorial changes have been made in this standard: ——the standard is renamed; ——The Annex A “Structural changes of this standard with respect to ISO 7886-1: 2017” is added. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights. This standard was proposed by China State Food and Drug Administration. The previous editions of this standard are as follows: ——GB 15810-1987, GB 15810-1995 and GB 15810-2001. Introduction As a single device, sterile syringes for single use needs to be combined with sterile injection needle for single use for clinical application. This standard encourages the manufacturers to treat the syringe together with the supporting injection needle as sales units, the structures and terms related to injection needles have therefore been added into the "syringe illustration". Considering that syringes without injection needles shall not be restricted, syringes without injection needles specified in this standard shall be used in conjunction with the sterile injection needles for single use meeting those specified in GB 15811. If the syringe itself is equipped with an injection needle, the chemical and biological properties shall be tested with the extract prepared with the injection needle mounted on the syringe. ISO 594-1: 1986 corresponding to GB/T 1962.1-2015 and ISO 594-2: 1998 corresponding to GB/T 1962.2-2001 have been replaced by ISO 80369-7: 2006, and the corresponding professional standard converted is YY/T 0916.7 (under approval). Sterile syringes for single use 1 Scope This standard specifies the nomenclature, physical requirements, chemical requirements, biological requirements, packaging, marking and storage of sterile syringes for single use (hereinafter referred to as "syringes"). This standard is applicable to syringes for manual use for liquid suction or injection immediately after liquid suction. This standard does not apply to insulin syringes, glass syringes, syringes permanently with needles, syringes with power-driven syringe pumps, self-destruct syringes with fixed dose vaccine, syringes to prevent reuse, syringes pre-loaded with liquid medicine by manufacturers and syringes matched with liquid medicine. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement (GB/T 1962.1-2015; ISO 594-1: 1986, IDT) 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; ISO 594-2: 1998, IDT) GB/T 6682 Water for analytical laboratory use - Specification and test methods (GB/T 6682-2008; ISO 3696: 1987, MOD) GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipment for medical use - Part 1: Chemical analysis methods GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods YY/T 0466.1 Medical devices- Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (YY/T 0466.1-2016; ISO 15223-1: 2012, IDT) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 nominal capacity capacity of the syringe as designated by the manufacturer Examples: 1 mL, 5 mL and 50 mL. 3.2 graduated capacity volume of water, at 18 °C to 28 °C, expelled from the syringe when the fiducial line on the plunger stoppers traverses a given scale interval or intervals 3.3 total graduated capacity capacity of the syringe at the graduation line furthest from the zero graduation line Note: The total graduated capacity may be equal to or greater than the nominal capacity. 3.4 maximum usable capacity capacity of the syringe when the plunger stopper is drawn back to its furthest functional position 3.5 fiducial line leading edge on the plunger stopper that is in contact with and perpendicular to the syringe barrel and aligns with the zero marking on the syringe barrel when the piston is fully inserted 3.6 two-piece syringe syringe assembly comprises the barrel and piston (3.12), whereas plunger and plunger stopper form one component made of the same material 3.7 three-piece syringe syringe assembly includes the barrel and piston (3.12), whereas plunger and plunger stopper are two separate components made of different materials 3.8 nozzle cap sheath intended to physically protect the nozzle prior to use 3.9 plunger stoppers seal assembly between the barrel and the plunger 3.10 plunger device component which advances the plunger stopper (3.9) to deliver the medicinal product 3.11 dead space residual volume of fluid left in syringe when the plunger stopper (3.9) is fully depressed 3.12 piston assembled component of plunger (3.10) and plunger stopper (3.9) 3.13 barrel flanges ergonomic and easy-to-hold raised part on the barrel 3.14 needle cap or shield sheath intended to physically protect the needle prior to use 4 Nomenclature The nomenclature for the components of the syringes is shown in Figure 1. Keys: 1——needle cap or shield (if used); 10——plunger cap; 2——nozzle cap; 11——barrel flange; 3——nozzle lumen; 12——fiducial line; 4——nozzle; 13——nominal capacity line; 5——barrel; 14——graduation lines; 6——plunger stopper; 15——zero line; 7——seals; 16——needle tube; 8——plunger; 17——hub; 9——push-button; Note: This figure is only used to illustrate the structure of a syringe, which is not the only type required by this standard. Figure 1 Schematic representation of syringe 5 Physical requirements 5.1 Appearance 5.1.1 When observed with naked eye of normal vision or vision corrected to normal acuity under the illumination of 300 lx~700 lx, the surface of the syringe contacting with the injection liquid during normal use shall be clean and free of particles or foreign matters. 5.1.2 The syringes shall be free of raw edges, burrs, plastic flow and defects. 5.1.3 The syringe barrel shall have sufficient clarity to enable the fiducial line to be read without difficulty. 5.1.4 When the plunger stopper is fully depressed to the bottom of the barrel, lubricant applied shall not enter the nozzle lumen.

Foreword i Introduction v 1 Scope 2 Normative references 3 Terms and definitions 4 Nomenclature 5 Physical requirements 5.1 Appearance 5.2 Tolerance on graduated capacity 5.3 Graduated scale 5.4 Barrel 5.5 Piston 5.6 Nozzle 5.7 Performance 6 Chemical requirements 6.1 Acidity or alkalinity 6.2 Content of extractable metals 6.3 Readily oxidizable substance 6.4 Residual quantity of ethylene oxide 7 Biological requirement 7.1 General 7.2 Sterility 7.3 Bacterial endotoxin 8 Packaging 8.1 Primary packaging 8.2 Medium packaging 9 Marking 9.1 General 9.2 Primary packaging 9.3 Medium packaging 9.4 Large packaging 9.5 Transport wrapping 10 Storage Annex A (Informative) Structural changes of this Standard with respect to ISO 7886-1: Annex B (Normative) Test method for capacity tolerance and dead space Annex C (Normative) Test method for liquid leakage of syringe at plunger stoppers or seal(s) under positive compression Annex D (Normative) Test method for leakage past piston or seal(s) during aspiration, and for separation of plunger stopper and plunger Annex E (Normative) Test method for sliding performance Annex F (Normative) Test method for fitting between syringe barrel and piston Annex G (Normative) Preparation of extracts and test method Annex H (Informative) Guidelines for design and materials Bibliography

一次性使用無菌注射器 1 范圍 本標準規定了一次性使用無菌注射器(以下簡稱“注射器”)的命名、物理要求、化學要求、生物要求、包裝、標志、貯存等。 本標準適用于供抽吸液體或抽吸液體后立即注射用的手動注射器。 本標準不適用于胰島素注射器、玻璃注射器、永久帶針注射器、帶有動力驅動注射泵的注射器、自毀型固定劑量疫苗注射器、防止重復使用注射器、由制造廠預裝藥液的注射器以及與藥液配套的注射器等。 2規范性引用文件 下列文件對于本文件的應用是必不可少的。凡是注日期的引用文件，僅注日期的版本適用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改單)適用于本文件。 GB/T 1962.1 注射器、注射針及其他醫療器械6％(魯爾)圓錐接頭 第1部分：通用要求(GB/T 1962.1—2015，ISO 594-1：1986，IDT) GB/T 1962.2 注射器、注射針及其他醫療器械6％(魯爾)圓錐接頭 第2部分：鎖定接頭(GB/T 1962.2—2001，ISO 594-2：1998，IDT) GB/T 6682分析實驗室用水規格和試驗方法(GB/T 6682—2008，ISO 3696：1987，MOD) GB/T 14233.1—2008醫用輸液、輸血、注射器具檢驗方法 第1部分：化學分析方法 GB/T 14233.2醫用輸液、輸血、注射器具檢驗方法 第2部分：生物學試驗方法 YY/T 0466.1 醫療器械 用于醫療器械標簽、標記和提供信息的符號 第1部分：通用要求(YY/T 0466.1—2016，ISO 15223-1：2012，IDT) 3術語和定義 下列術語和定義適用于本文件。 3.1 公稱容量 nominal capacity 由制造廠標示的注射器容量。 示例：1 mL，5 mL，50 mL。 3.2 刻度容量 graduated capacity 當活塞的基準線軸向移動給定的刻度間隔時，從注射器中排出的溫度為18℃～28℃的水的體積。 3.3 總刻度容量total graduated capacity 從零刻度線到最遠刻度線之間的注射器容量。 注：總刻度容量可以等于或大于公稱容量。 3.4 最大可用容量maximum usable capacity 當活塞拉開至其最遠端的功能位置時，注射器的容量。 3.5 基準線 fiducial line 活塞末端的環形線，與注射器外套接觸并垂直，當活塞組件被完全推至外套底端時，與注射器外套上的零刻度線對齊。 3.6 二件式注射器two-piece syringe 注射器包括外套、活塞組件(3.12)，而芯桿和活塞是由相同材料制成的注射器的一個部件。 3.7 三件式注射器three-piece syringe 注射器包括外套、活塞組件(3.12)，而芯桿和活塞是不同材料的兩個獨立的部件。 3.8 錐頭帽nozzle cap 使用前對錐頭的保護組件。 3.9 活塞plunger stoppers 外套與芯桿之間密封組件。 3.10 芯桿plunger 推動活塞(3.9)以便輸送藥液的裝置。 3.11 殘留容量dead space 當活塞(3.9)被完全推入時，注射器內部殘留的液體體積。 3.12 活塞組件piston 芯桿(3.10)和活塞(3.9)組成的組合件。 3.13 外套卷邊barrel flanges 外套上符合人體工程學便于握持的凸起部分。 3.14 針管保護套或防護裝置needle cap or shield 用于在使用前對針進行物理保護的防護裝置。 4命名 注射器各部分的名稱如圖1所示。 說明： 1——針管保護套或防護裝置(如有)； 10——芯桿保護套； 2——錐頭帽； 11——外套卷邊； 3——錐頭腔； 12——基準線； 4——錐頭； 13——公稱容量線； 5——外套； 14——刻度線； 6——活塞； 15——零刻度線； 7——密封圈； 16——針管； 8——芯桿； 17——針座。 9——按手； 注：本示意圖僅說明注射器的結構，并非為本標準規定的唯一型式。 圖1 注射器示意圖 5 物理要求 5.1 外觀 5.1.1 在300 lx～700 lx的照度下，用正常視力或矯正至正常的視力通過肉眼觀察，注射器在正常使用中與注射液接觸的表面應清潔、無微粒、無異物。 5.1.2注射器不應有毛邊、毛刺、塑流、缺損。 5.1.3注射器外套應有足夠的透明度，能清晰地看到基準線。 5.1.4當活塞被完全推至外套底端時，潤滑劑不應進入錐頭腔。 5.2刻度容量允差 刻度上的允差應符合表1的要求。 表1 容量允差、殘留容量、分度值及泄漏試驗力 注射器的 公稱容量V mL 容量允差(見附錄B) 最大 殘留 容量 mL 公稱容量 線標尺總長的最小全長 mm 最大分度值mL 標尺上數 字的最大增量 mL 器身密合性所用力(見附錄C) 小于公稱 容量的一半 等于或大于公稱容量的一半 側向力(±5％) N 軸向壓力(表) (±5％) kPa V<2 ±(V的1.5％+排出體積的2％) 排出體積的±5％ 0.07 57 0.05 0.1 0.25 300 2≤V<5 ±(V的1.5％+排出體積的2％) 排出體積的±5％ 0.07 27 0.2 1 1.0 300 5≤V<10 ±(V的1.5％+排出體積的1％) 排出體積的±4％ 0.075 36 0.5 1 2.0 300 10≤V<20 ±(V的1.5％+排出體積的1％) 排出體積的±4％ 0.10 44 1.0 5 2.0 300 20≤V<30 ±(V的1.5％+排出體積的1％) 排出體積的±4％ 0.15 52 2.0 10 3.0 200 30≤V<50 ±(V的1.5％+排出體積的1％) 排出體積的±4％ 0.17 67 2.0 10 3.0 200 V≥50 ±(V的1.5％+排出體積的1％) 排出體積的±4％ 0.20 75 5.0 10 3.0 200 5.3 刻度標尺 5.3.1 標尺 5.3.1.1 注射器應有一個或一個以上相同的標尺，且標尺刻度應符合表1的分度值。容量單位應標注在外套上。標尺和刻度線數字標示的舉例見圖2。 注1：標尺的垂直線可以省略。 注2：“零”字可以省略。 注3：圖示未按比例。 圖2標尺和刻度的舉例示意圖 5.3.1.2如果標尺超過了公稱容量，其延長的附加標尺與公稱容量標尺應加以區別。其區別方法如下： a)把公稱容量的數字用圓圈圈起來； b)附加標尺的數字用更小的數字表示； c)附加標尺的分度容量線用更短的刻度線表示； d)附加標尺長度的垂直線用虛線表示。 5.3.1.3 刻度容量線應粗細均勻，并應位于與外套軸線成直角的平面上。 5.3.1.4 刻度容量線應在零位線至總刻度容量線之間沿外套縱軸均勻分隔。 5.3.1.5 當注射器保持垂直位置時，所有等長的刻度容量線的末端應在垂直方向上相互對齊。 5.3.1.6 次刻度容量線長度約為主刻度容量線長度的二分之一。 5.3.2標尺上的數字 刻度線應按表1規定的最大增量值標示。如果公稱容量線與總刻度容量線不一致時，應用數字標示。將注射器垂直握住，錐頭向上，數字應垂直位于標尺上，且應處于相應的容量刻度延長線的中心對分位置上。數字應接近，但不應接觸相應刻度線的末端。 5.3.3公稱容量線的標尺總長 標尺總長應符合表1的要求。 5.3.4標尺位置 將活塞被完全推至外套底端時，標尺的零刻度線與活塞上的基準線應對齊，其誤差應符合表1中容量允差的要求。 5.3.5標尺的印刷 5.3.5.1 偏頭式注射器的標尺應印在錐頭的對面一側。 5.3.5.2 中頭式注射器的標尺應印在外套卷邊短軸的任意一側。 5.3.5.3 刻度容量線和數字印刷應完整、字跡清楚、線條清晰、粗細均勻。 5.4外套 5.4.1 尺寸 外套的長度應使注射器的最大可用容量至少比公稱容量大10％。 5.4.2外套卷邊 應確保注射器任意放置在與水平成10°夾角的平面上時不應轉過180°，且無銳邊和毛刺。 5.5 活塞組件 5.5.1 按手間距 當活塞的基準線與零刻度線對齊時，按手間距L應不小于8 mm，見圖3。 圖3 按手間距示意圖 5.5.2活塞與芯桿的配合 按附錄D試驗，活塞不應與芯桿分離。 5.6 錐頭 5.6.1 圓錐接頭 應符合GB/T 1962.1或GB/T 1962.2的要求。 5.6.2 錐頭位置 5.6.2.1 公稱容量小于5 mL的注射器，注射器應是中頭式，錐頭與外套在同一軸線上。 5.6.2.2公稱容量為5 mL及以上的注射器，注射器可以是中頭式或是偏頭式。 5.6.2.3 如果注射器是偏頭式，當注射器的標尺位于最上方時，錐頭軸線應位于外套軸線的垂直下方。錐頭軸線和外套內表面上最近一點之間的距離應不大于4.5 mm。 5.6.3錐頭腔內徑 應不小于1.2 mm。 5.7 性能 5.7.1 殘留容量 按附錄B中B.2試驗，在活塞被完全推入至外套底端，注射器的最大殘留容量應符合表1的要求。 5.7.2器身密合性 按附錄C試驗，活塞或密封圈處應無液體泄漏現象。 按附錄D試驗，活塞或密封圈處應無氣體泄漏現象，且壓力表的讀數不應持續下降。 5.7.3 滑動性能 按附錄E試驗，滑動性能力值應符合表2的要求。 表2滑動性能力值 注射器的公稱容量 V/mL 最大初始力 FS/N 最大平均力 F/N 最大推力 Fmax/N V<2 10 5 <(2.0×測量F)或(測量F+1.5 N)中較高者 2≤V<50 25 10 <(2.0×測量F)或(測量F+1.5 N)中較高者 V≥50 30 15 <(2.0×測量F)或(測量F+1.5 N)中較高者 5.7.4外套與活塞組件的配合 按附錄F試驗，活塞組件不應由于自身和水的質量產生移動。 6 化學要求 6.1 酸堿度 用電位式pH計和相應的通用電極進行測定時，按附錄G中G.1制備的萃取液的pH與空白液的pH之差應≤1。 6.2可萃取金屬含量 按附錄G中G.1制備萃取液，用經過確認的微量分析方法(例如原子吸收法或電感耦合等離子體發射光譜法)進行試驗，注射器萃取液中鉛、錫、鋅和鐵的總量應≤5 μg/mL，其鎘的含量應≤0.1 μg/mL。 6.3 易氧化物 按附錄G中G.1制備20 mL萃取液，按GB/T 14233.1—2008中5.2.2方法二進行試驗，注射器萃取液與等體積的同批空白對照液相比，0.002 mol/L的高錳酸鉀溶液消耗量之差應≤0.5 mL。 6.4環氧乙烷殘留量 若采用環氧乙烷滅菌，應對環氧乙烷殘留量控制進行確認。按附錄G中G.2進行試驗，環氧乙烷殘留量應≤10 μg/g。 7 生物要求 7.1 總則 注射器參照附錄H給出的指南選擇適宜的材料，并進行生物相容性評價。 7.2 無菌 每一初包裝內的注射器應選擇適宜的方法進行滅菌，應對滅菌過程進行確認和常規控制，以保證產品上的細菌存活概率小于10-6。滅菌過程的確認應形成文件。 注：GB/T 14233.2中規定了無菌試驗方法，該方法適用于型式檢驗而不適用于出廠檢驗。適宜的滅菌和出廠無菌檢驗方法見GB 18278.1、GB 18279.1或GB 18280.1。 7.3細菌內毒素 按GB/T 14233.2規定的方法試驗，細菌內毒素限量每支應不超過20 EU。 8 包裝 8.1 初包裝 若配注射針，注射針應與注射器密封在初包裝內，在確保注射器不被污染的情況下，也允許單獨包裝的注射針放入初包裝內。 采用環氧乙烷滅菌時，注射器初包裝應至少一面采用具有透氣功能的材料(如透析紙)。 本標準鼓勵采用透氣效果更好的包裝材料。包裝材料不應對內裝物產生有害影響。此包裝的材料和設計應確保： a)在干燥、清潔和充分通風的貯存條件下，能保證內裝物無菌； b)在從包裝中取出時，內裝物受污染的風險最小； c)在正常的搬動、運輸和貯存期間，對內裝物有充分的保護； d)一旦打開，包裝不能輕易地重新密封，而且應有明顯的被撕開的痕跡。 8.2 中包裝 一件或更多件初包裝，應裝入一件中包裝中。 在正常搬運、運輸和貯存期間，中包裝應能充分有效地保護內裝物。 一件或更多件中包裝，可以裝入大包裝中。 9標志 9.1 總則 所有標志符號應符合YY/T 0466.1的要求。 9.2 初包裝 初包裝上至少應有以下標志； a)內裝物的說明，包括公稱容量； b)“無菌”字樣或圖形符號； c)“一次性使用”或圖形符號； d)如果需要，提供對溶劑不相容性的警告； e)生產批號； f)制造廠或供應商的名稱和地址； g)失效期； h)若配注射針，應注明針管公稱外徑和公稱長度； i)在使用前檢查密封完整性的警示。 9.3 中包裝 中包裝上至少應有以下標志： a)內裝物的說明，包括公稱容量、數量； b)“無菌”字樣或圖形符號； c)“一次性使用”或圖形符號； d)生產批號； e)失效期； f)制造廠或供應商的名稱和地址； g)若配注射針，應注明針管公稱外徑和公稱長度。 9.4 大包裝 如果中包裝裝入了大包裝，大包裝上至少應有以下標志： a)內裝物的說明，包括公稱容量、數量； b)生產批號； c)“無菌”字樣或圖形符號； d)失效期； e)制造廠或供應商的名稱和地址； f)搬運、貯存和運輸的要求； g)若配注射針，應注明針管公稱外徑和公稱長度。 9.5運輸包裝材料 如果未使用大包裝，但中包裝物被包裝起來運輸，9.4要求的內容應被標在運輸包裝材料上，或者應能透過包裝材料識別9.4要求的內容。 10貯存 經滅菌的注射器應貯存在無腐蝕性氣體，通風良好和清潔的室內，并對注射器有充分的保護。