EN ISO 10993-1:1997
(Main)Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997)
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997)
Biologische Beurteilung von Medizinprodukten Teil 1: Beurteilung und Prüfung (ISO 10993-1:1997)
Dieser Teil der ISO 10993 beschreibt: a) die allgemeinen Grundprinzipien, die für die biologische Beurteilung von Medizinprodukten gelten; b) die Einteilung von Medizinprodukten in Kategorien auf der Basis des Applikationsortes und der Kontaktdauer mit dem menschlichen Körper; c) die Auswahl geeigneter Prüfverfahren. ISO 10993 gilt nicht für Prüfungen von Materialien und Produkten, die nicht direkt oder indirekt mit dem Körper des Patienten in Kontakt kommen.
Evaluation biologique des dispositifs médicaux - Partie 1: Evaluation et essais (ISO 10993-1:1997)
Biološko ovrednotenje medicinskih pripomočkov - 1. del: Ocena in preskusi (ISO 10993-1:1997)
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biologische Beurteilung von Medizinprodukten Teil 1: Beurteilung und Prüfung (ISO 10993-1:1997)Evaluation biologique des dispositifs médicaux - Partie 1: Evaluation et essais (ISO 10993-1:1997)Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997)11.100.20Biological evaluation of medical devicesICS:Ta slovenski standard je istoveten z:EN ISO 10993-1:1997SIST EN ISO 10993-1:2000en01-januar-2000SIST EN ISO 10993-1:2000SLOVENSKI
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SIST EN ISO 10993-1:2000
SIST EN ISO 10993-1:2000
SIST EN ISO 10993-1:2000
AReference numberISO 10993-1:1997(E)INTERNATIONALSTANDARDISO10993-1Second edition1997-12-15Biological evaluation of medical devices —Part 1:Evaluation and testingÉvaluation biologique des dispositifs médicaux —Partie 1: Évaluation et essaisSIST EN ISO 10993-1:2000
ISO 10993-1:1997(E)©
ISO 1997All rights reserved. Unless otherwise specified, no part of this publication may be reproducedor utilized in any form or by any means, electronic or mechanical, including photocopying andmicrofilm, without permission in writing from the publisher.International Organization for StandardizationCase postale 56 · CH-1211 Genève 20 · SwitzerlandInternetcentral@iso.chX.400c=ch; a=400net; p=iso; o=isocs; s=centralPrinted in SwitzerlandiiContentsPage1Scope.12Definitions.13General principles applying to biological evaluation of medicaldevices.24Categorization of medical devices.35Testing.46Selection of biological evaluation tests.77Assurance of test methods.7AnnexesARationale.10BFlow chart to aid in systematic approach to biological evaluationof medical devices.11CBibliography.12SIST EN ISO 10993-1:2000
© ISOISO 10993-1:1997(E)iiiForewordISO (the International Organization for Standardization) is a worldwidefederation of national standards bodies (ISO member bodies). The work ofpreparing International Standards is normally carried out through ISOtechnical committees. Each member body interested in a subject for whicha technical committee has been established has the right to be representedon that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISOcollaborates closely with the International Electrotechnical Commission(IEC) on all matters of electrotechnical standardization.Draft International Standards adopted by the technical committees arecirculated to the member bodies for voting. Publication as an InternationalStandard requires approval by at least 75 % of the member bodies castinga vote.International Standard ISO 10993-1 was prepared by Technical CommitteeISO/TC 194, Biological evaluation of medical devices.This second edition cancels and replaces the first edition(ISO 10993-1:1992), which has been technically revised.ISO 10993 consists of the following parts, under the general title Biologicalevaluation of medical devices:—Part 1: Evaluation and testing—Part 2: Animal welfare requirements—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity—Part 4: Selection of tests for interactions with blood—Part 5: Tests for cytotoxicity: in vitro methods—Part 6: Tests for local effects after implantation—Part 7: Ethylene oxide sterilization residuals—Part 9: Framework for the identification and quantification of potentialdegradation products—Part 10: Tests for irritation and sensitization—Part 11: Tests for systemic toxicity—Part 12: Sample preparation and reference materials—Part 13: Identification and quantification of degradation products frompolymers—Part 14: Identification and quantification of degradation products fromceramicsSIST EN ISO 10993-1:2000
ISO 10993-1:1997(E)© ISOiv—Part 15: Identification and quantification of degradation products frommetals and alloys—Part 16: Toxicokinetic study design for degradation products andleachablesFuture parts will deal with other relevant aspects of biological testing.Annexes A, B and C of this part of ISO 10993 are for information only.SIST EN ISO 10993-1:2000
© ISOISO 10993-1:1997(E)vIntroductionThis part of ISO 10993 is a combination/harmonization of numerousInternational and national Standards and guidelines concerning thebiological evaluation of medical devices. It is intended to be the overallguidance document for the selection of tests enabling evaluation ofbiological responses relevant to the safety of medical devices andmaterials.The role of this part of ISO 10993 is to serve as a framework in which toplan such a biological evaluation which minimizes the number andexposure of test animals.The protection of humans is the primary goal of ISO 10993.The appropriate selection and interpretation of biological evaluation testsrequires an understanding of the rationale behind such testing. Aninformative rationale for the use of this part of ISO 10993 is provided inannex A. Annex B contains a flow chart to aid in the systematic approachto the biological evaluation of medical devices. Annex C contains aninformative bibliography.SIST EN ISO 10993-1:2000
SIST EN ISO 10993-1:2000
INTERNATIONAL STANDARD
© ISOISO 10993-1:1997(E)1Biological evaluation of medical devices —Part 1:Evaluation and testing1 ScopeThis part of ISO 10993 describesa) the general principles governing the biological evaluation of medical devices;b) the categorization of devices based on the nature and duration of their contact with the body;c) the selection of appropriate tests.This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirectcontact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other partsof ISO 10993 cover specific tests as indicated in the foreword. (See also the rationale in A.2.)2 DefinitionsFor the purposes of this part of ISO 10993, the following definitions apply.2.1
medical device: Any instrument, apparatus, appliance, material or other article, including software, whetherused alone or in combination, intended by the manufacturer to be used for human beings solely or principally for thepurpose of:—diagnosis, prevention, monitoring, treatment or alleviation of disease;—diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or handicap;—investigation, replacement or modification of the anatomy or of a physiological process;—control of conception.and which does not achieve its principal intended action in or on the human body by pharmacological,immunological or metabolic means, but which may be assisted in its function by such means.NOTES1
Devices are different from drugs, and their biological evaluation requires a different approach.2
Use of the term “medical device” includes dental devices.2.2
material: Any synthetic or natural polymer, metal, alloy, ceramic, or other nonviable substance, includingtissue rendered nonviable, used as a medical device or any part thereof.2.3
final product: Medical device in its “as-used” state.SIST EN ISO 10993-1:2000
ISO 10993-1:1997(E)© ISO23
General principles applying to biological evaluation of medical devices3.1
The selection and evaluation of any material or device intended for use in humans requires a structuredprogramme of assessment.In the design process, an informed decision shall be made and documented that weighs theadvantages/disadvantages of the various choices of material and test procedure. To give assurance that the finalproduct will perform as intended and be safe for human use, the programme shall include a biological evaluation.The biological evaluation shall be planned, carried out, and documented by knowledgeable and experiencedindividuals capable of making informed decisions based on the advantages and disadvantages of the variousmaterials and test procedures available.3.2
In the selection of materials to be used in device manufacture, the first consideration should be fitness forpurpose with regard to characteristics and properties of the material, which include chemical, toxicological, physical,electrical, morphological and mechanical properties.3.3
The following should be considered for their relevance to the overall biological evaluation of the device:a) the material(s) of manufacture;b) intended additives, process contaminants and residues;c) leachable substances;d) degradation products;e) other components and their interactions in the final product;f) the properties and characteristics of the final product.NOTE —
If appropriate, identification and quantification of extractable chemical entities of the final product should precedebiological evaluation (see ISO 10993-9).3.4
Tests and their interpretation to be used in biological evaluation should take into account the chemicalcomposition of the materials, including the conditions of exposure as well as the nature, degree, frequency andduration of exposure of the device or its constituents to the body. By following these principles, devices can becategorized to facilitate the selection of appropriate tests (see clause 4). This part of ISO 10993 is concerned withthe tests to be carried out on materials and/or the final product.The range of potential biological hazards is wide and may include:a) short-term effects (e.g. acute toxicity, irritation to the skin, eye and mucosal surfaces, sensitization, haemolysisand thrombogenicity);b) long-term or specific toxic effects [e.g. subchronic and chronic toxic effects, sensitization, genotoxicity,carcinogenicity (tumorigenicity) and effects on reproduction including teratogenicity].3.5
All potential biological hazards should be considered for every material and final product, but this does notimply that testing for all potential hazards will be necessary or practical (see clause 6).3.6
Any in vitro or in vivo tests shall be based on end-use applications and appropriate good laboratory practicefollowed by evaluation by competent informed persons. Whenever possible, in vitro screening should be carried outbefore in vivo tests are commenced. Test data, complete to the extent that an independent analysis could be made,shall be retained (see A.2, subclause 3.6).SIST EN ISO 10993-1:2000
© ISOISO 10993-1:1997(E)33.7
The materials or final product shall be considered for biological re-evaluation if any of the following occurs:a) any change in the source or in the specification of the materials used in the manufacture of the product;b) any change in the formulation, processing, primary packaging or sterilization of the product;c) any change in the final product during storage;d) any change in the intended use of the product;e) any evidence that the product may produce adverse effects when used in humans.3.8
The biological evaluation performed in accordance with this part of ISO 10993 should be considered inconjunction with the nature and mobility of the ingredients in the materials used to manufacture the device and otherinformation, other non-clinical tests, clinical studies, and post-market experience for an overall assessment (seeA.2, subclause 3.8).4
Categorization of medical devicesFollowing the general principles laid down in clause 3, medical devices can be categorized to facilitate the selectionof appropriate tests.The testing of any device that does not fall into one of the categories described should follow the general principlescontained in this part of ISO 10993. Certain devices may fall into more than one category, in which case testingappropriate to each category should be considered.4.1
Categorization by nature of body contactMedical devices shall be categorized according to the nature of body contact as follows:4.1.1
Non-contact devicesMedical devices that do not contact the patient's body directly or indirectly are not included in the scope ofISO 10993.4.1.2
Surface-contacting devicesThese include medical devices in contact with the following surfaces:a) skin: devices that contact intact skin surfaces only; examples include electrodes, external prostheses, fixationtapes, compression bandages and monitors of various types;b) mucosal membranes: devices that contact intact mucosal membranes; examples include contact lenses,urinary catheters, intravaginal and intraintestinal devices (stomach tubes, sigmoidoscopes, colonoscopes,gastroscopes), endotracheal tubes, bronchoscopes, dental prostheses, orthodontic devices and intrauterinedevices;c) breached or compromised surfaces: devices that contact breached or otherwise compromised bodysurfaces; examples include dressings or healing devices and occlusive patches, for ulcers, burns, andgranulation tissue.4.1.3
External communicating devicesThese include medical devices in contact with the following application sites:a) blood path, indirect: devices that contact the blood path at one point and serve as a conduit for entry into thevascular system; examples include solution administration sets, extension sets, transfer sets and bloodadministration sets;SIST EN ISO 10993-1:2000
ISO 10993-1:1997(E)© ISO4b) tissue/bone/dentin: devices that contact tissue, bone or pulp/dentin systems; examples include laparoscopes,arthroscopes, draining systems, dental cements, dental filling materials and skin staples;c) circulating blood: devices that contact circulating blood; examples include intravascular catheters, temporarypacemaker electrodes, oxygenators, extracorporal oxygenator tubing and accessories, dialyzers, dialysistubing and accessories, haemoadsorbents and immunoadsorbents.4.1.4
Implant devicesThese include medical devices in contact with the following application sites:a)tissue/bone:1)devices principally contacting bone; examples include orthopaedic pins, plates, replacement joints, boneprostheses, bone cements and intraosseous devices;2)devices principally contacting tissue and tissue fluid; examples include pacemakers, drug supply devices,neuromuscular sensors and simulators, replacement tendons, breast implants, artificial larynxes,subperiostal implants and ligation clips;b)blood: devices principally contacting blood; examples include pacemaker electrodes, artificial arteriovenusfistulae, heart valves, vascular grafts, internal drug-delivery catheters and ventricular assist devices.4.2
Categorization by duration of contactMedical devices shall be categorized according to the duration of contact as follows:a) limited exposure (A): devices whose single or multiple use or contact is likely to be up to 24 h;b) prolonged exposure (B): devices whose single, multiple or long-term use or contact is likely to exceed 24 hbut not 30 days;c) permanent contact (C): devices whose single, multiple or long-term use or contact exceeds 30 days.If a material or device may be placed in more than one duration category, the more rigorous testing requirementsshould apply. With multiple exposures to the device, the decision into which category a device is placed should takeinto account the potential cumulative effect, bearing in mind the period of time over which these exposures occur.5
Testing5.1
GeneralIn addition to the general principles laid down in clause 3, the following shall apply to biological testing of medicaldevices.a) Testing shall be performed on the final product, or representative samples from the final product or materials.b) The choice of test procedures shall take into account:1)the nature, degree, duration, frequency and conditions of exposure to or contact of humans to the device inthe normal intended use;2)the chemical and physical nature of the final product;3)the toxicological activity of the chemical elements or compounds in the formulation of the final product;4)that certain tests (e.g. those designed to assess systemic effects) m
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