ISO TS 17665-3-2013 Sterilization of health care products - Moist heat - Part 3 Guidance on the designation of a medical device to a product family and processi.pdf

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3、 to develop customized sterilization processes to sterilize medical devices or combinations of medical devices that pose a particular challenge to the pre-set sterilization processes. The designs and nature of materials used to construct medical devices are increasing in complexity. Materials used i

4、n the manufacture of sterile barrier systems and/or packaging systems and the combinations of different medical devices in procedure sets can adversely affect conductivity, air removal and moist heat penetration, causing a failure to obtain the required sterility assurance level. The classification

5、of a medical device into a product family can assist with the development of moist heat sterilization process conditions for this medical device. Assigning a medical device to a particular product family is the first stage of performance qualification at the point of use as specified in ISO 17665-1

6、and ISO/TS 17665-2. The efficacy of sterilization for a medical device using the sterilization process for that product family should be assessed and documented together with any pre-treatments, such as cleaning, disinfection to reduce bioburden followed by lubrication and humidification of some mat

7、erials e.g. those containing cellulose. In this part of ISO 17665 the attributes which relate to efficient sterilization and which are used to identify a product family have been selected from operational experience, engineering considerations and experimental data relating to the efficacy of the di

8、fferent types of moist heat sterilizers and their sterilization processes, and the types and design of differing medical devices and sterile barrier systems and/or packaging systems. Medical devices that are labelled by the manufacturer as being capable of being sterilized via moist heat may be cate

9、gorized into product families by a user. However, not all medical devices will fit into one of the product families described in this part of ISO 17665. In these cases, new product families will need to be identified based on the consideration of the products attributes and require additional perfor

10、mance qualification. Medical devices that have been classified into different product families are often processed in the same sterilization load when assembled into a randomly selected load configuration. This approach is common and acceptable in health care facilities where it is generally not fea

11、sible to qualify each sterilization load, provided that the sterilization process and sterilizer have been shown to be capable of sterilizing the range of product families constituting the sterilization load. Care should be taken to ensure that the combination of product families does not create a g

12、reater sterilization challenge than that set by the individual product families. In addition, consideration should be given to possible adverse interactions between medical devices such as the contamination of instruments with textile fibres. The examples shown in Annex B and D are illustrations of

13、how the coding system is intended to be used in developing a sterilizer load. This part of ISO 17665 should be read in conjunction with ISO 17665-1 and ISO/TS 17665-2. ISO 2013 All rights reserved v Sterilization of health care products Moist heat Part 3: Guidance on the designation of a medical dev

14、ice to a product family and processing category for steam sterilization 1 Scope This part of ISO 17665 provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it to a proce

15、ssing category for a specific moist heat sterilization process. NOTE While this part of ISO 17665 is applicable to health care facilities, it may be used by a manufacturer of a sterile medical device and/or whenever information on reprocessing is required (see ISO 17664). 2 Normative references The

16、following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 17665-1

17、: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 3 T erms a nd definiti ons For the purposes of this document, the terms and definitions given in ISO 17665-1 and the followi

18、ng apply. 3.1 master product medical device or procedure set used to represent the most difficult to sterilize item in a product family or processing category 3.2 processing category collection of different products or product families that can be sterilized together 3.3 steam penetration resistance

19、 challenge to a sterilization process from a medical device, including any sterile barrier/packaging system that may delay attainment of the process parameters for moist heat sterilization on all parts of the medical device 3.4 user responsible body, which can be an individual or group, accountable

20、for ensuring products are sterilized and suitable for intended use TECHNICAL SPECIFICATION ISO/TS 17665-3:2013(E) ISO 2013 All rights reserved 1 ISO/TS 17665-3:2013(E) 4 Classific ation Each medical device, whether new or modified, should be classified using the general attributes listed in Table 1.

21、 Specific characteristics of a medical device should, as applicable, be identified from the subclauses detailed in 4.2. NOTE 1 Requirements for information to be provided by the manufacturer for the reprocessing of resterilizable medical devices are given in ISO 17664. If a collection of medical dev

22、ices are to be contained in a sterile barrier system and/or packaging system e.g. a procedure set, the challenge to the sterilization process from each medical device should be rated relative to the other medical devices as described in this part of ISO 17665. The product family assigned to this col

23、lection should be determined by the medical device which presents the greatest challenge to the sterilization process and the sterile barrier system and/or packaging system used. This product family will enable an appropriate processing category and sterilization process to be selected. The combinat

24、ion of the device with the highest rating and the chosen sterilization process should be subject to qualification in accordance with ISO 17665-1. NOTE 2 Requirements and guidance for sterile barrier systems and packaging systems may be found in ISO 11607 (all parts) and EN 868 (all parts). Some comb

25、inations of physical characteristics, such as those specified in Table 1, may cause an unpredictable adverse change to the steam penetration resistance as illustrated in Table 6. This can lead to an underestimation of the difficulty to sterilize (see Clause 5, Example 2). In such situations performa

26、nce qualification should always be carried out in accordance with ISO 17665-1. 4.1 General attributes Table 1 General attributes Attribute Code Design a Weight b Material c Sterile barrier system d 4.2 Detailed attributes The following attributes provide detail for characterizing a medical device an

27、d a sterilization process. Increased resistance to steam penetration is indicated by ascending code numbers. Some attributes will be specified by the manufacturer of the medical device and others by the user. The manufacturer of a medical device will usually specify the attributes needed by the user

28、 to assess its steam penetration resistance and to select a processing category for a specific sterilizer and sterilization process. Both the resistance and the category should be reassessed when the medical device is to be combined with others in a sterile barrier system and/or packaging system. Th

29、e sterilization process should be qualified to verify that the required lethality will be delivered to all medical devices processed together (see ISO 17665-1 and ISO/TS 17665-2). 4.2.1 Design For the purpose of identifying a type of sterilization process for reprocessing and assigning a processing

30、category, a medical device should be broadly identified from one or more of the designs described in Table 2. The steam penetration resistance will be different for each design when air is to be removed and replaced by saturated steam. The following should be considered when developing an air remova

31、l process.2 ISO 2013 All rights reserved ISO/TS 17665-3:2013(E) a1: air is displaced predictably as temperature rises with the introduction of steam. This action is unlikely to be affected by orientation. a2: instrument may need to be in an open position and an active air removal process may be nece

32、ssary. a3: residual air in hollows may cause unpredictable delays to sterilizing conditions. Defined orientation and/or the dilution of air by an active air removal process may be necessary. a4: inadequate removal of air during the air removal stage of the sterilization process can cause uncertainty

33、 in the attainment of sterilizing conditions. a5: an active air removal process will be required. Condensate resulting from temperature differences within materials, interaction between adjacent medical devices and the quality of steam can cause an adverse effect on the efficiency of air dilution. a

34、6: an active air removal process will be required. Condensate can cause occlusion, inadequate air removal and inadequate steam penetration. a7: if an active air removal process is required, develop the sterilization process to the product. Table 2 Design Structure Code (a) Example Solid, hollow 1 Bo

35、wl, jug, dish, bottle, chisel, single piece skin retractor, single component empty instrument tray Pin and box joints 2 Scissor, forceps, needle holder Lumen 3 Laparoscopic sheath, sucker, cannulated reamer, rigid endoscope, cannulated screws Porous 4 Linen, filters, gauze Tubing, moving parts, tort

36、uous paths 5 Power tool hose, silicone tubing, dental hand piece, ear nose throat drill, Lumen surrounded by a large mass 6 Drill, cannulated screw driver, obturator, ratchet handle, bored handle Other 7 Pre-filled syringe 4.2.2 Material The materials used to manufacture a medical device will be eit

37、her metallic or non-metallic or a combination of both. Typically, metallic materials will have a high thermal conductivity and non-metals will have low thermal conductivity. Materials with low thermal conductivity exhibit higher temperature differences throughout the material when compared to materi

38、als with high thermal conductivity. Both types of material present challenges to the sterilization process. The moisture content of the material may also influence the heat transfer into the product. This should be taken into account during performance qualification with the material in its most cha

39、llenging state. When compared to materials with low thermal conductivity, materials with high thermal conductivity and equal heat capacity will: initially generate more condensate in a given time period, absorb and release energy faster, attain a state of equilibrium faster. ISO 2013 All rights reserved 3