Manual Cleaning Validation of Reusable Medical Devices: AAMI ST98 and ISO 17664

Before a reusable medical device such as a surgical instrument or an endoscope accessory reaches the market, the manufacturer has to put cleaning, disinfection and sterilization steps in the instructions for use and show by testing that those steps actually work. This article explains what each of the documents commonly used for manual cleaning validation covers, which of them the SUNGO Shanghai laboratory is accredited for, the limitations written into that accreditation, and what to prepare before sending samples.

The short answer

• Shanghai only. The work is done by the laboratory of Shanghai SUNGO Medical Technology Co., Ltd. The certificates held by the Hefei laboratory do not include any of the standards discussed here.
• CNAS (L22083): AAMI ST98:2022 and AAMI TIR30:2011/(R)2016. The accredited item is "cleaning validation", and the scope states the limitation "只做乙醇清洁剂手动清洗效果试验", which translates as "manual cleaning efficacy testing with ethanol cleaning agent only".
• IAS (TL-1019): ANSI/AAMI ST98 and AAMI TIR30 are accredited for manual cleaning validation only. AAMI TIR12, ISO 17664-1 and ISO 17664-2 are accredited only for manual cleaning validation, manual disinfection (disinfectant) and the half cycle sterilization method. For YY/T 0802.1 and YY/T 0802.2 the scope states no limitation. The IAS scope lists standard numbers without edition years.
• No CMA. None of these standards appears in the Shanghai laboratory's CMA schedule (240015340087), so these reports do not carry the CMA mark.
• Processing methods outside the stated limitations are not accredited. The accreditation for ST98, TIR30, TIR12 and ISO 17664-1 and -2 is bounded by the limitations above. For YY/T 0802.1 and .2 the scope states no limitation, and whether a specific processing method falls within scope is confirmed method by method before the work is accepted.

The standards and what they cover

ANSI/AAMI ST98:2022: the requirements standard for cleaning validation

ST98, Cleaning validation of health care products — Requirements for development and validation of a cleaning process for medical devices, is published by the Association for the Advancement of Medical Instrumentation (AAMI). According to the abstract in the FDA Recognized Consensus Standards database, it covers the requirements to validate cleaning processes that the device manufacturer develops for processing medical devices. It applies to all medical devices that need cleaning before each clinical use, and those uses can be in health care facilities, in the home or by first responders. FDA lists ANSI/AAMI ST98:2022 as a recognized consensus standard (recognition number 14-583, entered 2022-12-19, complete standard).

As the co-chair of the AAMI Cleaning of Reusable Medical Devices Working Group (ST-WG93) explained in AAMI News in August 2022, ST98 differs from TIR30 in two main ways. ST98 has a wider scope: it applies to devices that need processing before clinical use according to the Spaulding classification, including single-use devices that the health care facility must process before use. And where TIR30 only gave an overview of cleaning test methods, ST98 sets out requirements for cleaning validation.

AAMI TIR30:2011/(R)2016: superseded by ST98

TIR30, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, is a technical information report written as a resource for manufacturers who must validate their reprocessing instructions. AAMI now labels it a historical document. AAMI states that it has been superseded by ANSI/AAMI ST98:2022, is no longer maintained, and should not be used for new designs.

AAMI TIR12: guidance on processing instructions

TIR12, Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers, gives manufacturers guidance on writing processing instructions. According to the FDA database abstract, those instructions run from pre-treatment at the point of use through the terminal process and storage, for reusable and single-use devices that a health care facility processes before clinical use. FDA lists AAMI TIR12 as a recognized consensus standard (recognition number 14-602, complete standard). FDA recognition applies to the edition listed in the database entry; see the entry itself for details.

ISO 17664-1 and ISO 17664-2: information the manufacturer must provide

The ISO 17664 series does not write processing instructions for the manufacturer. Instead, it sets requirements for the information the manufacturer has to provide where applicable: initial treatment at the point of use, preparation before cleaning, cleaning, disinfection, drying, inspection and maintenance, packaging, sterilization, storage and transportation. Part 2 starts with preparation before processing and does not include point-of-use treatment or sterilization.

• ISO 17664-1 (Critical and semi-critical medical devices): for devices that enter normally sterile parts of the body, devices that contact mucous membranes or non-intact skin, and devices intended to be sterilized.
• ISO 17664-2 (Non-critical medical devices): for devices not intended to be sterilized that contact only intact skin or have no direct patient contact.
• Neither part covers: textile devices used in patient draping systems or surgical clothing, or devices the manufacturer specifies for single use only and supplies ready for use.

FDA recognizes the two parts to different extents. ISO 17664-2 is recognized as a complete standard (14-579). ISO 17664-1 is partially recognized (14-578): clauses 6.6.1.1, 6.7.1.1, 6.8 and 6.11.3 i) are not recognized because FDA considers them to conflict with the corresponding sections of its reprocessing guidance. FDA recognition applies to the edition listed in each database entry. Processing instructions written for the US market therefore need to be checked against the FDA guidance as well.

YY/T 0802.1 and YY/T 0802.2: the Chinese industry standards

According to China's National Public Service Platform for Standards Information, YY/T 0802.1—2024 and YY/T 0802.2—2024 were both published on 2024-09-29 and took effect on 2025-10-15, fully replacing YY/T 0802—2020. The IAS scope gives their English titles as Processing of medical device — Information to be provided by the medical device manufacturer — Part 1: Critical and semi-critical medical devices, and Part 2: Non-critical medical devices. The way the two parts divide their scope corresponds to ISO 17664-1 and -2. For the formal adoption relationship with the ISO standards, see the foreword of each standard. The SUNGO IAS scope lists these two standards without edition years.

The FDA reprocessing guidance and how cleaning validation is approached

FDA issued the guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling on 2015-03-17 and updated its Appendix E on 2017-06-09. The guidance says that validation of the reprocessing instructions should be complete before a 510(k) is submitted. For the device types listed in Appendix E, the 510(k) should include the validation protocols and complete test reports. For other reusable devices, FDA does not expect the complete validation report in the 510(k), but the manufacturer should keep the data on file, and FDA may request it where needed.

Sections VII and VIII of the guidance give recommendations for cleaning validation that are useful when designing a protocol. The specific requirements are those in the text of ST98.

• Run each step of the instructions under its worst-case condition (shortest time, lowest temperature, weakest dilution and so on), and compare the instruction text with the validation protocol line by line. The guidance names enzymatic detergents as an exception to validating at the lowest temperature, because they typically have an optimally effective temperature range; the protocol should address the temperature range given in the instructions. See the guidance text for details.
• Test the devices that are hardest to reprocess and most heavily soiled (Section VIII). Within a product family, the hardest-to-reprocess device can cover devices that present an equivalent or lesser challenge, but their design features should be evaluated and the justification well documented (Section VII).
• The artificial test soil should represent what the device is exposed to in clinical use and should allow at least two clinically relevant soil components to be quantified (the guidance gives total organic carbon and protein as examples). It should be applied to every location likely to contact patient material, including hard-to-clean areas. Devices at risk of soil build-up should go through multiple simulated-use cycles.
• Use at least two quantitative test methods that directly measure clinically relevant soil, set the cleaning endpoints in advance, and inspect internal and external surfaces visually.
• Validate both the test methods and the extraction method, include negative and positive controls, and determine recovery efficiency. Extraction should sample all surfaces, including internal surfaces such as lumens, and mated surfaces.
• The guidance does not recommend using log reduction of spores or other microbial markers to judge whether a cleaning method is effective.

Before sending samples, please check with us whether the analytes and methods you plan to use fall within the accredited scope listed below.

Accredited test items (from the certificate scopes)

The tables below list the relevant lines of the certificate scopes. In the CNAS table, the item, edition and limitation are given as they appear in the original; the CNAS scope is in Chinese, so an English translation is given in brackets. Each line of the IAS scope gives only the standard number, the standard title and any limitation, with no separate item, so the Item column of the IAS table shows the standard title from the scope.

CNAS scope (L22083)

IAS scope (TL-1019)

Points to note when reading the tables:

• The CNAS limitation covers both the cleaning agent and the method. If the instructions specify a cleaning agent other than ethanol, or a cleaning method other than manual, the test is outside the CNAS scope.
• For ST98 and TIR30, the IAS limitation reads "Only accredited for manual cleaning validation". Whether a project using a cleaning agent other than ethanol can be reported under IAS is confirmed case by case before the work is accepted.
• Manual disinfection (disinfectant) and the half cycle sterilization method appear only in the IAS limitations for TIR12 and ISO 17664-1 and -2. Neither appears in the CNAS or CMA scope. How the half cycle sterilization method is carried out follows the text of the relevant standard and the protocol agreed between the client and the laboratory.
• YY/T 0802.1 and .2 set out what processing information the manufacturer must provide. The scope states no limitation for them, but when a particular processing step is to be validated by testing, the specific method still has to be checked against the accredited scope.
• Standards that appear only in the IAS scope cannot be reported under CNAS or CMA. TIR12, ISO 17664-1 and -2, and YY/T 0802.1 and .2 appear only in the IAS scope.

Where the work is done and under which accreditation

• Location: No. 958 Kangqiao East Road, Pudong New Area, Shanghai.
• Legal entity: Shanghai SUNGO Medical Technology Co., Ltd., an independent legal entity.
• CNAS: L22083; scope as in the table above. The CNAS certificate states that CNAS is a signatory to the ILAC and APAC mutual recognition arrangements.
• IAS: TL-1019; scope as in the table above. The IAS certificate carries the ilac-MRA mark.
• CMA: 240015340087. None of the standards in this article is in its schedule. The CMA mark may be used only for items in the schedule, and the certificate states that it is valid within the People's Republic of China.

Hefei SUNGO Medical Technology Co., Ltd. (Zipeng Town, Feixi County, Hefei) is a separate legal entity, and its certificates do not include the standards in this article. Whether a particular regulator accepts a report depends on that regulator's requirements. At the start of a project, confirm which accreditation (CNAS or IAS) and which edition of each standard you need.

Preparing for testing

1. Product information: a list of models and sizes. If you are validating a product family, name the representative model and explain why it is the hardest to reprocess (lumens, materials, construction, surface texture and so on).
2. Construction and configuration: drawings or photos marking lumens, hinges, crevices, mated surfaces and detachable parts, plus disassembly and reassembly instructions.
3. The processing instructions to be validated: the full text of the cleaning section of the instructions for use, giving the cleaning agent's name, concentration, contact time, temperature, and the brushing and flushing method. If manual disinfection or half cycle sterilization is also to be validated, include those sections too. Note that manual disinfection (disinfectant) and the half cycle sterilization method are within the IAS (TL-1019) scope only for TIR12 and ISO 17664-1 and -2.
4. Clinical use: what the device contacts in clinical use (for example blood, mucus or tissue), and whether soil may dry on the device before processing.
5. Sample condition: whether the samples are new or have been through simulated use, and whether they have already been processed. The number of samples is set by the protocol and the applicable standard.
6. Cleaning agent and disinfectant information: the specified product's name, manufacturer and instructions for use.
7. Target market and report requirements: the registration region, the documents and editions to follow, and the accreditation the report needs.

Frequently asked questions

Can AAMI TIR30 still be used?

AAMI labels TIR30:2011/(R)2016 as a historical document. It states that TIR30 has been superseded by ANSI/AAMI ST98:2022 and should not be used for new designs. The SUNGO CNAS and IAS scopes list both ST98 and TIR30, and new projects are best designed to ST98.

Can SUNGO issue a CMA report for cleaning validation?

No. None of the standards in this article is in the Shanghai laboratory's CMA schedule. Reports can be issued within the CNAS or IAS scope, subject to the limitations of each.

The instructions specify manual cleaning with a non-ethanol cleaning agent. Is that within the accredited scope?

It is outside the CNAS scope, which is limited to manual cleaning efficacy testing with ethanol cleaning agent only. The IAS limitation for ST98 and TIR30 reads "Only accredited for manual cleaning validation". Whether a project using a cleaning agent other than ethanol can be reported under IAS is confirmed case by case before the work is accepted.

Which processing methods does SUNGO's cleaning validation accreditation cover?

Under CNAS (L22083), ST98:2022 and TIR30:2011/(R)2016 cover manual cleaning efficacy testing with ethanol cleaning agent only. Under IAS (TL-1019), ST98 and TIR30 are accredited for manual cleaning validation only, and TIR12 and ISO 17664-1 and -2 only for manual cleaning validation, manual disinfection (disinfectant) and the half cycle sterilization method. For YY/T 0802.1 and .2 the IAS scope states no limitation, and the specific method is confirmed before the work is accepted.

How do I choose between ISO 17664-1 and ISO 17664-2?

Part 1 applies to devices that enter normally sterile parts of the body, contact mucous membranes or non-intact skin, or are intended to be sterilized. Part 2 applies to devices not intended to be sterilized that contact only intact skin or have no direct patient contact. In China, the standards with the corresponding scopes are YY/T 0802.1 and YY/T 0802.2.

Requesting a quote

See our cleaning, disinfection and sterilization validation service, then send an enquiry through the contact page. Please include the models and sizes, the processing instructions to be validated, the target market and the accreditation you need. We will confirm whether the work falls within the accredited scope described above before discussing the validation protocol with you.