ISO 10993-1 pdf download – Biological evaluation of medical devices一 Part 1: Evaluation and testing within a risk management process

ISO 10993-1 pdf download - Biological evaluation of medical devices一 Part 1: Evaluation and testing within a risk management process

ISO 10993-1 pdf download – Biological evaluation of medical devices一 Part 1: Evaluation and testing within a risk management process.
The results ol the risk analysis of identified dwiuicals can lead to the conclusion that additional material characterizaiion is necessary. Appropriate extraction testing, can be used to eStimate the degree of clinical exposure to the chemical constituent (see 1St) 10993-Ill). The acceptability of the level of estimated leachables shall be established by comparing the amount oleach compound extracted front (hi medical device to its respective relevant toxicological threshold as developed in accordance with
ISo 10993-17.
NOTE Forexampic’, when the margin 01 salety is not considered adequate ii the entire aniount of a particular chemical is leached out during use, appropriate extrattion testing can be used.
Protection of hunians is the priiliary goal of this document; a secondary goal is to ensure animal welfare and to minimize (hi’ number and exposure of the test ;ininials. 1St) 10993-2 applies to any in vito testing lwing considered. Addit ion,il in vivo testing shall not 1w carried out where
1) results are available from relevant studies that have heeii carried (iLit previously, or
2) the existing non-clinical antI clinical dati, Induding history (II sale use, meet the requirements of biological evaluation and therefore further animal testing would be unethical. In assessing the relevance of data on prior use of a material to the biological evaluation. the level of tonlitlence in the historical data should be takeit into account. ISO 10993-18:2005. Annex C. gives soimie informative principles for tidging chemical equivalence.
6.3 Biological testing
6.3.1 General
In addition to the general principles given in Clause 4. the following shall apply when biological testing at niedical devices is oiisidered necessary is part of the overall risk management process.
a) Testing shall be pc’rformc’d on the fitial medical device, or representative samples Ironi the final device or materials processed in the same manner as the lmnal medical device (including sterilization. ir needed).
b) The choice of test procedures shall take into account:
I) the nature, degree, duration, frequency and conditions of exposure to or contact of humans with the medical device in the normal intended use;
2) the chentical and physical nature of the final inc’dlcal device;
3) the toxicological activity of the chemicals in the formulation of the final medical device;
4) that certain biological tests (i.e. those designed to assess systemic effects) are not jtistif table svhei’e (he presence of leachable chemicals has been excluded (in accordance with ISO t09J3-1H), or where chemicals have a known and acceptable toxicity profile, allowing the safe use by evaluation in accordance with ISO 10993-17 and risk assessment in accordance with ISO 14971;
S) the ratio of device surface area to recipient body size and niass (e.g. device miniaturization for implantation testing in animal models);
6) this existing information based on the literature, previous exlwrience and non-clinical tests:
7) the sensitivity and specificity of the test being considered in relation to the impact of the resulting data set on I he biological evaluation;
H) that ISO l09’i3-2:200G, 4.4. requires that any pain. sullering. distress or lasting harm to the animals used shall be minimized.
c) If extracts or the niedical devices are prepared, the solvents and conditions of extraction used should be appropriate to the nature and use of the final product, as well as to the predictability (such as test purpose, rationale. sensitivity. specificity, etc.) 01. the test method, and shall be prepared in accordance with ISO 10993-12. Wherwvc, possible, the extraction coiiditiuns selected should represent at a minimum, an exaggeratioll ot use conditions.
ti) Positive anti negative controls should 1w used where appropriate.
The test iiietliiids used In the biological evaluation tests shall be sensitive. pretise and accurate When biological testing is conducted, it shall 1w carried out in accordance with giunl laboratory practices.
N0T1 IS(J/WC 17023 or etloivalent
The teSt methods should he reproducible (intralahoratory) as well as repeatahle (intcrl.mhnratory) and robust,
6.3.2 Testing for evaluation
Testing for thc evaluations specified in 6.12.l to 6 t21S shall be considered and carmied out where necessary to complete the data sets needed for the biological evaluation of tlw particular nwtlmcal device. Where the existing data are mtlequate, additional testing is not required (see Annexes A and £).
Due to the diversity of devices, it is recognized that testing will not 1w necessary or practicable for all endpoints iclentitied in .i category (see 1Sf) 14971) for a given nwdiual device. It is indispensable for evaluations that each medical device he considered on its own merits. Nanomaterlals can pose siwtific challenges (e.g. assay iimteriereiicv) when applying test systtenls cimmimnionly tised [or itiedical device evaluation and when interpreting test results (see ISO/TR 10993-22).

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