ISO 18562-1:2017download free.Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process.
ISO 18562-1 represents the application of the best-known science, in order to improve PATIENT safety, by addressing the RISIC of potentially hazardous substances being conveyed to the PATIENT by the gas stream,
ISO 18562-1 Is intended to cover the biological evaluation GIGAS PATHWAYS of MEDICAL DEVICES within a RISK MANAGEMENT PROCESS, as part of the overall MEDICAL DEVICE evaluation and development. This approach combines the review and evaluation of existing data from all sources with, where necessary, the selection and application of additional tests.
In general. the ISO 10993 series is intended to cover the biological evaluation of MEDICAL DEVICES.
However, the ISO 10993 series does not sufficiently address the biological evaluation of the GAS
PATHWAYS of MEDICAL DEVICES.
Before ISO 18562-1 was developed, some AUTHORITIES HAVING JURISDICTION interpreted the
150 10993-1:2009, Table A.1 to mean that materials in the GAS PATHWAY form indirect contacC with
the PATIENT, and should be subfectcd to tests equivalent to those required for tissue contact parts of
MEDICAL DEVICES. ISO 18562-1 can lead to tests with questionable benefit and also to possible
HAZARDS not being detected.
ISO 10993.1:2009 states that it is not Intended to provide a rigid set of test methods as this might result Ifl an unnecessary constraint on the development and use of novel MEDICAL DEVICES. ISO 10993-1:2009 also states where a particular application warrants it, experts in the product or in the area of application concerned can choose to establish specific tests and criteria, described in a product-specific vertical standard. This new series of standards Is intended to address the specific needs for the evaluation of GAS PATHWAYS that are not adequately covered by ISO 10993-1:2009.
ISO 18562-1 provides a guide to the development of a biological evaluation plan that minimizes the number and exposure of test animals by giving preference to chemical constituent testing and in, vitro models.
the initial version of this series of standards was intended to cover only the most commonly found potentially harmful substances. It was felt that ii was best to get a functioning document published that would test for the bulk of the currently known substances of interest. With the use of the ‘rrc (THRESHOLD OF TOXICOLOGICAL CONCERN) approach, this document has the potential to be used to assess the safety of essentially any compound released from the GAS PATHWAYS of respiratory MEDICAL DEVICES, with very few exceptions (e.g. PCBs. dioxins), and not lust the most commonly found potentially harmful substances. Later amendments and additIonal parts are pLanned to explicitly cover less common substances.
In this document, the following print types are used:
— requirements and definitions: roman type;
— rest speclflcotton,s: ituik type-
— informative material appearing outside of tables, such as notes, examples and references: In smaller type. Normative text of tables is also in a smaller type;
— terms defined in Clause 3 of this DOCUMENT or as noted: small capitals
In this document, the con)unctive or Is used as an inclusive or” so a statement Is true if any combination of the conditions Is true.
The verbal forms used in this document conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
— shalI means that compliance with a requirement or a test is mandatory for compliance with this document;
3.12
THRESHOLO OF TOXICOLOGICAL CONCERN
TTC
level of exposure ror all chemicals, known or unknown, below which it Is considered there is no appreciable rnsx to human health
Note Ito entry: A ‘tic is used as an acceptable value For a is foe an unknown or Insufficiently characterised compound.
3.13
TOLERABLE EXPOSURE
TE
total amount or a substance (in units of pg/d) that a PATIENT can be exposed to per 24 h period that is
considered to be without appreciable harm to health
Note Ito entry: lEts also referred to as allowed dose to patient’. This amount ii specific to a particular PATIENT or PATIENT group of a given body weight.
Note 2 to entry: lx is calculated by multiplying TOLERABLE INTAKE by the body mass
3.14
TOLERABLE INTAKE
TI
TOLERABLE INTAKE LEVEL
TIL
total amount of a substance per kilogram of body weight (in units of .tg/kg body welght/d) that a
PATIENT can be exposed to per 24 ii period that is considered to be without appreciable harm to health
Note I to entry This amount is applicable br all PATIENT groups.
3.15
TYPE TEST
test on a representative sample of the MEDICAL DEVICE with the objective otdetcrmining tithe MEDICAL
DEVICE, as designed and manufactured, can meet the requirements of this document
Note 1 to entry: If the foal MEDICAL DEVICE IS not used for the assessments, all differences between the representahve sample’ and the final MEDICAL DEVICE need to be described and a justification provided for why the differences do not affect the outcome of the testing.
ISOURCE: IEC 60601’l:2005, 3.135, modified — substituted MEDIcAL DEVICE’ for ‘me equipment’ and added Note II
3.16
VOLATILE ORGANIC COMPOUND
voc
organic compound whose boiling point is in the range of 50 C to 260 C
Note I to entry: There are many varied definitions of Voc. For the purposes of this document, a Voc is a cacnpound that has a boiling poInt in the range olSO ‘C to 260 ‘C, at a standard atmospheric pressure of 101.3 kPa.
Note 2 to entry: Boiling points of some compounds are difficult as’ impossible to determine because they decompose before they boll at atmospheric pressure.
Note 3 to entry: Compounds s*ili exert a vapour pressure, and so could enter the breathing gas, at temperatures lower than their boiling point.
Note 4 tO entry: VOC does not include VERY VOLATILE ORGANIC COMPOUNDS (Yvocs) nor semi-volatile organic compounds (SVOCs). Additional parts of this document might be developed to address these substances in the future. Some AIJTHORmI€5 HAVING IURISDICTION require evaluation of these RISKS 55 part of a biological evaluation.
representative sample and the final MEDICAL DEVICE, and a detailed rationale for why each difference is not expected to impact the iuocosar*rtaiixrv of the final MEDICAL DEVICE.
NOTE Some AUTlft)RITIES HAVING IURISLHCTION evaluate these differences and rationales,
4.3 BI0C0MPATIRILrIY HAZARD identification
Identify all the possible mocoup*rtmu’rv-related HAZARDS that might reach the PATIENT via the GAS PATHWAYS during the use of the MEDICAL DEVICE.
All known possible wocoMrATIaiLrrv-related HAZARDS shall be taken Into account for every material and final MEDICAL DEVICE, part or ACCESSORY. This does not imply that testing for all possible HAZARDS is necessary or practical. ISO 10993.1:2009, Clause S and Clause 6 have additional requirements for additional types and durations OIPATIEP4T exposure.
EXAMPLE Fora MEDICAL DEVICE (such asa mask) that has direct PATIENT csmt.acl in addition to GAS PATHWAY contacL assessment Foi compliance to both ISO 18562-i and ISO 10993-1 can he required.
In the selection of materials to be used In GAS PAThWAY manufacture, the first consideration should be fitness for purpose with regard to characteristics and properties of the material, which includes physical, mechanical, chemical and toxicological properties.
Materials used to manufacture the components in the GAS PATHWAYS should be suitable for the IN1’ENDED uSE, and use materials with demonstrable history of safe use in the intended or comparable application wherever possible.
The following shall be taken into account for their relevance to the overall biological evaluation of the
GAS PATHWAY:
— the material(s) of manufacture;
— intended additives, nocess contaminants and residues;
— substances released in NORMAL use;
— degradation products from NORMAL USE that might pass Into the PATIENT via the GAS PATHWAYS;
NOTE 1 ISO 10993-91]) contaIns requirements for general principles and ISO l0993-1Zl, ISO 10993-14U1 and ISO 10993-1514) contain requirements for degradation products from polymers, ceramics and metals. respectively. II testing for degradation using dry heat only, then ISO 10993-13, ISO 10993-14 and ISO 10993-iS need not apply.
NOTE 2 NORMAL USE can include use with heated and humidified breathing gas. Tests are done on the worst case’ configuration. This can niean testIng with and without heat and humidifIcatIon to establish the worst case,
— other components and their interactions in the final MEDICAL DEVICE, part or ACCESSORY;
— the performance and characteristics of the final MEDICAL DEVICE, part or ACCESSORY;
physical characteristics of the final MEDICAL DEVICE, part or ACCESSORY including, but not limited to, porosity, particle size and shape:
— the effects of any hygienic processing steps required before use or re-use, if applicable. Check compliance by inspection of the RiSK MA NA GEt4If NT plan and RiSK MANAGiIi4fNT FiLE.
4.4 Extent of RISK ASSESSMENT
An analysis shall be made of the HAZARDS identified in 4.3. and the RISK that the HAZARD poses to the PATIENT determIned. The results shall be documented.
NOTE 1 ISO 10993-1:2009, Figure lIsa graphical representatlcrn iii the RISK ASSF.SSMENT PROCESS.
5 Contamination of breathing gas from GAS PATHWAYS
5.1 • Duration of use
The tests that a MEDICAL DEVICE. part or ACCESSORY shall be subjected to depend on the nature of the components in the GAS PATHWAY, its locatIon in the GAS PATHWAY, and Its duration of use on a PATIENT.
The tests and specified limits for a MEDICAL DEViCE may depend on Its Intended duration of use for a single PAT1ENT, This document addresses three different durations oF use:
— limited exposure — MEDICAL DEVICE, part or ACCESSORY whose cumulative single, multiple or repeated use is less than or equal to 24 h;
— prolonged exposure — MEDICAL DEVICE, part or ACCESSORY whose cumulative single, multiple or repeated long-term use is likely to exceed 24 h but be less than 3D ci:
NOTE I When determining hand what testing is needed fur MEDICAl. DEVICES that are In contact with the breathing gas, there are no differences In the biological effects for consideration between MEDICAL DEVICES with prolonged and permanent exposure.
— permanent contact — MEDICAL DEVICE, part or ACCESSoRY whose cumulative single, multiple or repeated long-term use is likely to be equal to or exceed 30 d
NOTE 2 The duratlon is durat ion of PATIENT exposure to the original plus subsequent replacement MEDICAL DEVICES, not duration of use of an Individual MEDICAL DEVICE. There can he components replaced every 1w days so multiple sequential exposures to new replacement MEDICAL DEVICES need to be considered.