Quick facts
- ISO 14160:2020 is the international standard for sterilization, by a liquid chemical sterilizing agent, of single-use medical devices that are made from or contain materials of animal origin. It is the third edition and it cancels and replaces ISO 14160:2011.
- Its requirements are written for sterilization carried out after the device has been manufactured. Nothing in it tells a clinic how to process a reusable instrument, and its validation clauses are addressed to the parties that build and run the manufacturing process.
- The scope excludes material of human origin, does not describe methods for validating the inactivation of viruses or transmissible spongiform encephalopathy agents, and does not cover the level of residual sterilizing agent inside the device — the ISO 10993 series carries the residue limit.
- In Canada the two ends of that chain sit in different device classes: a product intended for disinfecting or sterilizing a medical device is a Class II device under Rule 13 of Schedule 1 to the Medical Devices Regulations, while a device manufactured from or incorporating animal cells, tissues or their derivatives is Class IV under Rule 14.
A clinic team searching for the rule that governs the instrument in front of them can land on ISO 14160:2020 by following the words "liquid chemical sterilant". It is the wrong document for that question, and the reason is structural rather than technical: the standard sterilizes single-use devices on a production line, not reusable devices on a bench. Understanding what it does cover makes the boundary easier to hold, and the boundary is where most of the confusion in clinic purchasing conversations comes from.
What is ISO 14160:2020 actually for?
The standard's own scope states the subject precisely. It specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin. It covers the control of risks arising from contamination with bacteria and fungi; risks from other microorganisms can be assessed using other methods. It is not applicable to material of human origin. It does not describe methods for validating the inactivation of viruses or of TSE agents, and it does not describe validation of the inactivation or elimination of protozoa and parasites.
Two sentences in that scope do the heavy lifting for anyone outside manufacturing. The requirements for validation and routine control apply only to the defined sterilization process of a medical device, performed after the manufacturing process, and they do not take account of the lethal effects of other bioburden reduction steps. In other words, the standard validates one specific step in a production sequence, on the assumption that everything upstream has done its job. A clinic reprocessing a used instrument has no equivalent upstream: the cleaning step it performs is the entire upstream, and its performance is the variable the clinic cannot hold constant.
The edition history is straightforward and worth checking against any internal document that cites this standard. The third edition is dated 2020-09. It was prepared by ISO technical committee TC 198, Sterilization of health care products, in collaboration with the European Committee for Standardization technical committee CEN/TC 204, and it cancels and replaces the second edition, ISO 14160:2011, which it says has been technically revised. The United States Food and Drug Administration lists it in its recognised consensus standards database under recognition number 14-551, with the entry dated 21 December 2020.
Which clauses tell you this is a manufacturer's standard?
The clause list answers the question before any of the requirements are read. Table 1 sets out what each clause imposes and who, in the standard's own model, is the actor.
| Clause | What ISO 14160:2020 requires there | Who performs it in the standard's model | Why a clinic is not the actor |
|---|---|---|---|
| 1 Scope | Requirements for characterizing a liquid chemical sterilizing agent and for development, validation, process control and monitoring of sterilization of single-use devices containing animal-derived material | The manufacturer of the single-use device | The subject is a device that arrives sterile and is never reprocessed |
| 2 Normative references | ISO 10993-1 and ISO 10993-17 (biological evaluation and leachable limits), ISO 11737-1 (microorganism population), ISO 13408 all parts (aseptic processing) | The device manufacturer and its testing laboratories | The reference set is a manufacturing quality system, not a reprocessing room |
| 3 Terms and definitions | Includes liquid chemical sterilizing agent, parametric release, sterility assurance level, surrogate product, storage solution and tissue | The parties writing the validation protocol | The vocabulary is process validation, not instrument processing |
| 4 General | Document control, management responsibility, resources, control of externally provided product, identification and traceability, control of non-conforming product | The manufacturer's quality management function | Assumes a quality system that audits a supply chain |
| 5 Sterilizing agent characterization (5.1 to 5.5) | Agent identity, microbicidal effectiveness, effects on materials, safety and the environment | The manufacturer, with the supplier of the sterilizing agent | Requires controlled study data on the agent, not a product data sheet |
| 6 Process and equipment characterization (6.1 to 6.3) | Process characterization and equipment characterization | The manufacturer and the equipment supplier | Models a production-sized sterilizing installation |
| 7 Product definition | Defining the product, its variants and the worst case to be sterilized | The manufacturer | Product families are production items, not instrument trays |
| 8 Process definition (8.1 to 8.4) | Determining the inactivation kinetics (8.2), the method for neutralization (8.3), and safety, quality and performance (8.4) | The manufacturer's validation team | Requires inactivation curve data and a neutralization study |
| 9 Validation (9.1 to 9.5) | Installation qualification (9.2), operational qualification (9.3), performance qualification (9.4) split into microbiological performance qualification (9.4.2), physical performance qualification (9.4.3) and aseptic processing qualification (9.4.4), then review and approval (9.5) | The manufacturer, with approved protocols and reports | Assumes a qualification programme a clinic does not run |
| 10 Routine monitoring and control | Monitoring and control of the validated process in routine production | The manufacturer's production function | A clinic's routine monitoring is a daily indicator routine run under provincial rules |
| 11 Product release from sterilization | A defined release procedure, including parametric release where the process records support it | The manufacturer's release authority | Release is a batch decision taken before the device is packaged for sale |
| 12 Maintaining process effectiveness (12.1 to 12.4) | Maintenance of equipment (12.2), requalification (12.3), assessment of change (12.4) | The manufacturer | Change control belongs to the production site |
| Annex A (informative) | Guidance on applying the document | All users | Guidance only; not a requirement |
| Annex B (normative) | Determination of the lethal rate of the sterilization process | The validation team | Normative, and it is a calculation, not a bench procedure |
| Annex C (informative) | Flowchart linking microbicidal effectiveness (5.3), process definition (Clause 8) and microbiological performance qualification (9.4.2) | The validation team | An aid to reading the requirements |
The tell is Clause 2. When a standard's normative references are a biological evaluation standard, a leachables standard, a bioburden method and the aseptic processing series, the document is describing a manufacturing process with a quality system around it. A clinic reprocessing room shares vocabulary with that world — sterilization, validation, indicators — and shares almost none of its structure.
What does the scope exclude, and why do the exclusions matter?
Four exclusions carry real weight.
Material of human origin is outside the scope entirely. A device built from human tissue is a different regulatory object in Canada and a different standard set elsewhere.
Validation of the inactivation of viruses and TSE agents is not described. The standard notes that liquid chemical sterilizing agents traditionally used to sterilize animal tissues in medical devices might not be effective against the causative agents of TSE, and it directs that work to the ISO 22442 series. A reader who assumes a liquid chemical sterilizing agent validated under ISO 14160 also handles prion risk has crossed into a subject the standard explicitly hands off.
Validation of the inactivation or elimination of protozoa and parasites is likewise not described.
Residual sterilizing agent inside the device is not covered. The standard points to ISO 10993-17 for the establishment of allowable limits for leachable substances. That exclusion is the one a clinic can feel directly: a residue limit is established from an extractable and leachable study on the finished device, and there is no clinic-side equivalent that measures what a reused instrument retains after a chemical soak.
The standard also states two limits that are easy to misread as gaps rather than as boundaries. It does not specify tests to establish the effect of the chosen sterilization process on the fitness for use of the device, and it does not address whether the process leaves the device fit for its intended purpose. Both are properties the manufacturer has to establish through other means.
How does ISO 14160:2020 differ from ISO 17665, ISO 11135 and ISO 14937?
Four standards in the same family are routinely confused in clinic purchasing documents. Table 2 sets out the boundary.
| Standard | Sterilizing agent | Subject of the sterilization | Applies to a clinic reprocessing bench? |
|---|---|---|---|
| ISO 17665:2024 | Moist heat — saturated steam, and contained product processes | Medical devices, including devices reprocessed in health care facilities | Yes. Clause 1 states that the application in industrial and health care settings is considered, and Annex F is guidance for health care facilities |
| ISO 11135:2014 with Amendment 1:2018 | Ethylene oxide | Medical devices sterilized industrially, with defined health care applications | Only where a facility operates a validated ethylene oxide process, which a dental or medical office does not |
| ISO 14937:2009 | Any agent, when no dedicated standard exists | Medical devices, as a generic framework for characterizing an agent and validating a process | Its introduction treats devices presented for resterilization in accordance with the manufacturer's instructions as special cases, rather than as the primary subject |
| ISO 14160:2020 | Liquid chemical sterilizing agents | Single-use medical devices comprising, in whole or in part, materials of animal origin | No. The requirements apply to the process performed after manufacturing, on devices that arrive sterile |
One line from ISO 17664-1:2021 closes the loop from the other direction. That standard governs the processing information a device manufacturer must supply, and its scope excludes medical devices specified by the manufacturer for single use only and supplied ready for use. Devices inside ISO 14160:2020's scope are precisely devices that arrive ready for use. The reprocessing standard and the manufacturer-side sterilant standard divide the world cleanly, and a clinic sits on the ISO 17664-1 side of the line.
Which Canadian rule decides what a clinic may use?
Canadian device regulation answers the "what am I allowed to buy" question directly, and it does so through classification rather than through a list of approved chemicals.
Rule 13 of Schedule 1 to the Medical Devices Regulations separates two intents. A medical device intended to be used for disinfecting or sterilizing blood, tissues or organs intended for transfusion or transplantation is classified as Class IV. A medical device intended to be used for disinfecting or sterilizing a medical device is classified as Class II.
Rule 14 addresses the devices themselves. A medical device manufactured from or incorporating human or animal cells or tissues or their derivatives is classified as Class IV, as is a device incorporating a product produced through the use of recombinant DNA technology, unless it is intended to come into contact with intact skin only, in which case it is Class I.
Two consequences follow. A liquid chemical sterilant product sold to sterilize instruments is regulated as a device in its own right, at Class II, whether or not the standard behind its validation is ISO 14160. And a device that incorporates animal tissue — the population ISO 14160:2020 exists to sterilize — is Class IV, the highest risk class, with a licence application that must include objective evidence of the biological safety of the device. Device classification by intended use, rather than a permitted-substance list, is what the Canadian framework puts in front of a buyer.
Which claim can a product carry, and which cannot?
ISO 14160:2020 defines a liquid chemical sterilizing agent as a liquid chemical entity, or combination of entities, having sufficient microbicidal activity to achieve sterility under defined conditions. Sterility in the same definition set is the state of being free from viable microorganisms, with the accompanying note that in practice no absolute statement about the absence of microorganisms can be proven. Sterility assurance level is defined as the probability of a single viable microorganism occurring on an item after sterilization, expressed as a negative exponent to the base ten.
That combination is what separates a sterilizing claim from a disinfecting claim, and it separates the parties who may make each one. A manufacturer of a single-use device can declare the device sterile because it has characterized the agent, defined the process, qualified the equipment and validated the delivery — and, where the record supports it, can use parametric release, defined in the standard as a declaration that product is sterile based on records demonstrating that the process variables were delivered within specified tolerances. A clinic that immerses instruments in a chemical solution and rinses them has performed a chemical disinfection step; it has not characterized an agent, defined a process on a surrogate product, or qualified a sterilizing installation, and it cannot produce the record set that parametric release requires.
The practical split is therefore not about chemistry but about evidence. A product label that says the contents are sterile describes a manufacturing outcome. A clinic's own claim about an instrument has to rest on the provincial and college framework it operates under, not on the standard that governed the manufacture of a single-use animal-tissue device.
What does a Canadian clinic follow instead?
Three documents cover the clinic side, and none of them is ISO 14160.
The first is the manufacturer's processing information, required in the ISO 17664-1:2021 sense: the activities a reusable device is designed to survive, from initial treatment at the point of use through cleaning, disinfection, drying, inspection, packaging, sterilization and storage. A clinic that reprocesses outside those instructions has no validation basis for the outcome, whatever sterilizer it owns.
The second is the provincial monitoring framework. In Ontario, the college standard requires a biological indicator in a process challenge device on each day the sterilizer is used and for each type of cycle used that day, with a control test, and it sets the log book at a minimum of ten years from the date of the last entry. Provincial guidance in the same province states the same daily requirement for biological monitoring and adds a daily air removal test on dynamic air removal sterilizers. ISO 17665:2024 supplies the process requirements that sit underneath both.
The third is the national reprocessing standard, CAN/CSA-Z314, which replaced the older numbered parts. Together these three answer the question a clinic actually has: what process may I run, how do I monitor it, and what do I write down. ISO 14160:2020 answers a different question, for a different party, one step upstream.
For a clinic building the consumable side of that framework, the working set is the same whatever sterilant was used in manufacturing: a 24-hour self-contained biological indicator 25-pack for the daily cadence and its control, a fifteen-well dry-block incubator to run a day of indicators together, and a five-pack indicator trial to test the cadence before committing to a year. The sterilization compliance hub indexes the provincial and national requirements these articles quote, the sterilization monitoring collection gathers the monitoring lines, and multi-site clinics can open a wholesale account for case quantities.
Related reading
For the standard that applies when no dedicated document covers a process, see ISO 14937 and sterilizing agent characterization; for the three sterilizing modalities compared side by side, see ISO 17665, ISO 11135 and ISO 11137; for the statutory rule on reprocessing records and frequency, see spore test frequency after a major sterilizer repair and in daily practice; for what a chemical agent does and does not achieve on a bench, see autoclave versus incineration versus chemical treatment in medical waste terminology; for the biology behind the indicator, see the science of steam sterilization and how spores are inactivated; and for a province-by-province reading of the rules, see CSA Z314 versus CDC sterilization rules in Canada and the United States. and for the moist heat standard that does apply on a clinic bench, see ISO 17665:2024 read clause by clause against Canadian clinic practice.
Frequently Asked Questions
Does ISO 14160:2020 apply to a dental or medical clinic?
No. The standard specifies requirements for characterizing a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization, by such agents, of single-use medical devices comprising in whole or in part materials of animal origin. Its validation and routine control requirements apply only to the defined sterilization process performed after the manufacturing process. A clinic reprocessing reusable instruments is working under the manufacturer's processing instructions and its provincial reprocessing framework.
Can a clinic use a liquid chemical sterilant to sterilize instruments?
A clinic can use a chemical agent as part of a validated reprocessing sequence, and the result it can claim depends on the sequence and on the province's rules. What it cannot do is point to ISO 14160:2020 as the basis for that sequence: the standard's scope excludes reusable device reprocessing, and its residual-agent clause hands the leachable limit to ISO 10993-17, which is established from studies on the finished device.
Which Canadian class is a liquid chemical sterilant?
A medical device intended to be used for disinfecting or sterilizing a medical device is classified as Class II under Rule 13 of Schedule 1 to the Medical Devices Regulations. The same rule classifies as Class IV a device intended for disinfecting or sterilizing blood, tissues or organs intended for transfusion or transplantation. A sterilant sold to reprocess instruments and a sterilant sold to treat donor tissue are therefore in different classes.
Why does the standard not cover residual sterilizing agent left on the device?
Because that work has its own standard. The ISO 14160:2020 scope notes that the document does not cover the level of residual sterilizing agent within medical devices, and points to ISO 10993-17 for the establishment of allowable limits for leachable substances. The distinction matters in practice: the residue question is answered by extractable and leachable studies on a finished device, not by a contact time on a label.
Can a single-use device containing animal tissue be described as sterile?
A manufacturer that has characterized the agent, defined the process, qualified the equipment and validated the process can declare the device sterile, and where the records demonstrate the process variables were delivered within tolerances the declaration can be made by parametric release as defined in the standard. Sterility itself is defined as the state of being free from viable microorganisms, with the standard's own note that no absolute statement about the absence of microorganisms can be proven.
What should a clinic read instead of ISO 14160:2020?
The manufacturer's processing instructions for each reusable device, prepared in the ISO 17664-1:2021 sense; the provincial reprocessing and monitoring rules that apply to the clinic, including the daily biological indicator cadence in Ontario; and CAN/CSA-Z314, the national reprocessing standard for all health care settings. ISO 17665:2024 supplies the moist heat process requirements underneath the clinic's steam sterilizer.
CliniEco Medical holds MDEL #35334.
Sources
- ISO 14160:2020 — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — free preview with scope, clause list and annexes (PDF)
- ISO — catalogue record for ISO 14160:2020
- iTeh Standards — ISO 14160:2020 abstract and publication details
- FDA CDRH recognised consensus standards — ISO 14160, third edition, recognition number 14-551
- FDA CDRH recognised consensus standards — ISO 22442-3, validation of inactivation of viruses and TSE agents
- Health Canada — Medical Devices Regulations, SOR/98-282, consolidated text including Schedule 1 classification rules
- ISO 17664-1:2021 — Information to be provided by the medical device manufacturer for processing — free preview (PDF)
- ISO 17665:2024 — Moist heat sterilization, free preview showing scope, clauses and annexes (PDF)
- ISO 14937:2009 — General requirements for characterization of a sterilizing agent — free preview (PDF)
- ISO 10993-17:2023 — Establishment of allowable limits for leachable substances — free preview (PDF)
- ISO 11135:2014 with Amendment 1:2018 — Ethylene oxide sterilization, catalogue record
- RCDSO — Standard of Practice: Infection Prevention and Control, v3 (PDF)
- Public Health Ontario / PIDAC — provincial guidance for cleaning, disinfection and sterilization in all health care settings, 3rd edition (PDF)
- CSA Group — CAN/CSA-Z314, medical device reprocessing in all health care settings
- CliniEco Medical — sterilization compliance hub
- CliniEco Medical — ISO 14937 and sterilizing agent characterization
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