ISO 17665 — Standard

About the Standard

Scope title: sterilization by moist heat

ISO 17665 is a standard published by International Organization for Standardization (ISO). The international standards organisation; it publishes the widest body of management system, test method and product standards.

See the other 310 codes from ISO

Coverage areas

Medikal Cihaz Testleri — What Does This Testing Field Cover?

The section below describes the field that code ISO 17665 belongs to; it is not the text of the standard or the regime itself. The scope title of the code is given above, and technical requirements are shared at the quotation stage.

Medical device testing shows that a device is safe for the patient and the user and maintains its intended performance. In this family safety is not only about avoiding harm; a device failing to perform its expected function is also treated as a risk. A monitor missing an alarm or a pump delivering the wrong dose is directly a patient safety event.

At the centre of the field is RISK MANAGEMENT, and this is what sets medical apart from other sectors. The risk management process run under ISO 14971 also determines which tests are required. The test list is not copied from a table of standards; it is derived and justified from the device's intended use, the nature and duration of patient contact, the use environment and foreseeable misuse.

Assessment consists of several separate bodies of work, each with its own set of standards. Biocompatibility runs through the ISO 10993 series, electrical device safety through the IEC 60601 series, sterilisation through ISO 11135/11137/17665, packaging through ISO 11607, software through IEC 62304 and usability through IEC 62366. The quality system (ISO 13485) is the framework that binds these together.

Which tests are required is determined by the device's CLASS and its MODE OF CONTACT WITH THE BODY. A product in brief contact with skin and an implant entering the bloodstream do not go through the same test set; the scope is set by a biological evaluation plan prepared under ISO 10993-1. That plan justifies in writing which endpoints are required and why the others are not.

Packaging and sterilisation are taken as seriously as the device itself in this field. For a sterile device the packaging is not a transport container but the barrier that maintains sterility; if the barrier is breached, the device is no longer sterile. Packaging processes are therefore validated and shelf life is supported by real-time ageing data.

For devices containing software, assessment shifts from testing towards PROCESS assurance. IEC 62304 defines which development and verification steps must be followed according to the safety class of the software; the evidence is the traceability of the development process. Testing software does not make it safe — the process record does.

The clinical side is a separate column of the technical file. Test reports show that the device is technically safe; clinical evaluation establishes that the device delivers the intended clinical benefit and that the benefit-risk balance is acceptable. Neither replaces the other.

Method groups in this field

Biocompatibility
Cytotoxicity, irritation, skin sensitisation, systemic toxicity, haemocompatibility, genotoxicity and local effects after implantation. The required endpoints are set by the ISO 10993-1 plan.
Electrical device safety
IEC 60601-1 basic safety and essential performance; EMC, alarm, usability and environmental requirements through the collateral standards.
Sterilisation validation
Validation of sterilisation processes by ethylene oxide, radiation or moist heat; bioburden and sterility assurance level studies.
Packaging
Integrity of the sterile barrier system, seal strength, distribution simulation and shelf-life studies.
Microbiological tests
Bioburden determination, sterility testing, bacterial endotoxin and, where required, carrier validation studies.
Software and usability
IEC 62304 life cycle evidence and use-error focused evaluation under IEC 62366.

Commonly confused in this field

Cytotoxicity alone is not evidence of biocompatibility; the required set of endpoints is determined and justified according to ISO 10993-1.
An ISO 13485 certificate does not confer CE marking; classification under the MDR, the technical file and the notified body process run separately.
Accelerated ageing does not replace real-time ageing; a shelf life claim is supported by real-time data.
A change of material (supplier, pigment, sterilisation method) may require the biological evaluation to be repeated; it is not a silent change.
An assessment made without the collateral and particular standards for IEC 60601-1 is incomplete; which -1-x and -2-x standards were applied must appear in the report.
In vitro diagnostic devices fall under the IVDR rather than the MDR, and laboratory equipment is often on the IEC 61010-1 side.

Which decisions these results support

MDR/IVDR technical file and notified body assessment
Completing the biological evaluation plan
Sterilisation and packaging validation
Determining shelf life and storage conditions
Determining the scope of reassessment after a design change

Structure of the Code

Published by: ISO
Serial number: 17665
Part: without partition

Codes in the library without release year is kept. The current version changes over time; If the year is specified in your specification, that version is taken as basis, if not specified, the most current version is applied.

Scope

Medical Device Testing

Related Tests and Services

A separate test page based on this code has not yet been released. The code falls within the scope of the following test families.

Medical Device Testing

Technical Requirements

Standard texts are copyright of the relevant organization; test condition, sample and acceptance criteria cannot be fitted here.

Technical requirements specific to your product, once we clarify the scope At offer stage shared in writing.

Relevant Product Groups and Legislation

This code is included in the standard tag of the product pages below.

These product pages carry notes for the following markets: European Union, United Kingdom, USA. Whether the standard is mandatory in the relevant market varies depending on the product group and the applicable legislation.

Regulations published with this code on the same product pages:

(AB) 2018/858Vehicle Type-Approval FrameworkApproval of motor vehicles and their components. Component and separate technical unit approval run under this framework; the E mark arises from it.
UNECEUNECE 1958 AgreementType-approval under component-specific UNECE regulations (e.g. R10 EMC, R30/R54 tyres, R43 glazing).
UNECE R10UNECE R10Electromagnetic compatibility approval for vehicles and their components.
2011/65/EURoHSRestriction of hazardous substances in electrical and electronic equipment.
2000/53/ATELVEnd-of-life vehicles. Sets heavy-metal restrictions and recoverability targets.
(EU) 2017/745MDRThe Medical Device Regulation. Classification (I, IIa, IIb, III), clinical evaluation, technical documentation and post-market surveillance obligations; the notified body's role grows as the class rises.
(EU) 2017/746IVDRThe In Vitro Diagnostic Medical Devices Regulation. In vitro diagnostic devices fall under this regulation instead of the MDR.
(AB) 2017/745 art. 33EUDAMEDThe European medical device database. From 28 May 2026, the actor registration, UDI/device, certificate and market surveillance modules are mandatory; placing on the market is not possible without a valid SRN.
2006/42/ATMachinery Directive (overlap)Relevant essential requirements also apply to medical devices that also qualify as machinery.
(EC) 1907/2006REACHRegistration, evaluation, authorisation and restriction of chemicals; SVHC notification.
(EU) 2023/1230Machinery RegulationReplaces 2006/42/EC and becomes mandatory on 20 January 2027 with no further transition period. Requires notified-body involvement for Annex I high-risk machinery.
2014/35/EULVDThe Low Voltage Directive. Governs electrical safety in the 50–1000 V AC range.
2014/30/EUEMCThe Electromagnetic Compatibility Directive. Emission and immunity are covered together.
2014/34/ABATEXEquipment and protective systems used in explosive atmospheres. The category and conformity route are determined by zone classification.
2000/14/ATNoise EmissionNoise emitted into the environment by outdoor equipment. Machinery within scope requires a sound-power-level declaration and marking.
2014/68/EUPEDThe Pressure Equipment Directive for pressurised parts; the category is determined by pressure and volume.
(EU) 2024/573F-GasRefrigerant type, GWP value and leak-tightness obligations for systems containing a refrigerant.
(AB) 547/2012Ecodesign (water pumps)Ecodesign requirements for water pumps. Sets minimum efficiency index and product-information requirements.
(AB) 2019/1781Ecodesign (electric motors)Efficiency class requirements for electric motors and variable-speed drives.
(AT) 1935/2004Food Contact MaterialsGeneral requirements for equipment in contact with food; material conformity is required for valves in food lines.
(AB) 2020/2184Drinking Water Contact ProductsHygiene requirements for materials in contact with water under the Drinking Water Directive.
2014/29/ABSimple Pressure VesselsA separate directive for series-produced simple pressure vessels; its scope must be distinguished from the PED.
2010/35/ABTransportable Pressure EquipmentThe pi mark and periodic inspection regime for transportable pressure equipment.
2009/48/ECToy SafetyThe Toy Safety Directive. Regulates mechanical, physical, flammability, chemical and electrical safety requirements together; a technical file and safety assessment are mandatory.
EN 62115Electrical toysSafety for electric toys; applies to mains-connected or battery-powered toys.
(AT) 1907/2006 Annex XVII item 51-52Phthalate RestrictionRestriction of certain phthalates in toys and childcare articles.
(EU) 2023/1542Batteries RegulationBattery obligations and a removability requirement for toys containing a battery.
(AB) 1007/2011Textile LabellingTextile fibre names and labelling. Declaration of fibre composition and regulation of the label language.
(AT) 1907/2006 Annex XVII item 43Azo Dye RestrictionRestriction of certain azo dyes in textiles in contact with skin.
(AB) 2019/1021PFAS / PFOA RestrictionRestriction of PFOA and its derivatives under the Persistent Organic Pollutants Regulation.
(EU) 2023/988GPSRThe General Product Safety Regulation. The safety framework for consumer products not covered by sector-specific legislation.
(EU) 2016/425Personal Protective Equipment (overlap)The PPE Regulation's scope and category are determined for textiles with a protective function.
(AB) 10/2011Plastics in Food ContactPlastic materials in contact with food. The list of authorised substances, and overall and specific migration limits.
(AT) 2023/2006Good Manufacturing PracticeGood manufacturing practice (GMP) for food-contact materials.
(AB) 2025/40Packaging and Packaging WasteThe Packaging and Packaging Waste Regulation. Recyclability, recycled-content and packaging-reduction obligations; replaces 94/62/EC.
(AB) 2022/1616Recycled PlasticRecycled plastic materials in contact with food.
(EU) 2024/3110Construction Products RegulationDeclaration of performance and CE marking for construction products. Most provisions apply from 8 January 2026; it progressively replaces (EU) 305/2011.
(AB) 305/2011CPR (transition)Continues to apply during the transition period for product groups where a new harmonised standard has not been published.
EN 13501-1Reaction-to-Fire ClassificationReaction-to-fire class for construction products; a mandatory item of the declaration of performance.
(EU) 2023/1115Deforestation (wood-based)A deforestation-free supply declaration for wood and derived construction materials.
(AT) 1223/2009Cosmetic Products RegulationThe Cosmetic Products Regulation. Appointing a responsible person, the product information file (PIF), the safety assessment (CPSR) and CPNP notification are mandatory; there is no product approval, and responsibility rests with the manufacturer.
(AT) 1223/2009 Annexes II-VIProhibited and Restricted SubstancesLists of prohibited substances, restricted substances, and permitted preservatives, colorants and UV filters.
(AT) 1223/2009 art. 16Nanomaterial NotificationA separate notification six months before placing on the market for products containing nanomaterials.
(AT) 1223/2009 art. 18Animal Testing BanA ban on animal testing of finished products and ingredients, and on placing animal-tested products on the market.
(AT) 178/2002General Food LawThe general principles of food law, traceability and food safety responsibility.
(AT) 852/2004Food HygieneHygiene rules for food businesses and the obligation for a HACCP-based system.
(AB) 1169/2011Food Information to ConsumersFood labelling; nutrition declaration, allergen information and origin information.
(AB) 2023/915ContaminantsMaximum levels of contaminants in food.
(AT) 396/2005Pesticide residuesMaximum residue limits in food of plant and animal origin.
(AT) 2073/2005Microbiological CriteriaMicrobiological criteria for foodstuffs.

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