PPT ON ISO 17644-1 2023 Instructions from the Manufacturers to trainer

1. ISO 17644-1 2021

2. Trainer Miss. Fizza khan Presented by Maroof Faheem

3. ISO 17644-1 2021 Introduction

4. Introduction The ISO 17664-1:2021 standard provides essential guidance for medical device manufacturers to ensure safe and effective processing of critical and semi-critical medical devices. Key Features Ensure that reusable devices are cleaned, disinfected, and/or sterilized properly. Support prevention of infection and cross-contamination Define manufacturer responsibilities in providing validated processing instructions. Address advancements in medical and processing technology Minimize risks related to device functionality and safety

5. ISO 17644-1 2021 Scope

6. Scope ISO 17664-1:2021 specifies requirements for information provided by manufacturers for the processing of critical and semi-critical medical device. Applicable to: Critical Medical Devices Semi-Critical Devices Covers processing activities such as: Initial treatments Cleaning and disinfection Drying, inspection, and maintenance Packaging, sterilization, storage, and transportation

7. Manufacturers Responsibilities Validation of the Processes Risk Analysis Provision of Information Processing Instructions Limitations and Restrictions Presentation of the Information

8. Validation of the Processes Medical device manufacturers are required to validate all processes identified in the instructions for processing their devices. Key requirements: Each process must be validated to demonstrate it is suitable for processing the specific device. Objective evidence must confirm the device will be clean, disinfected and/or sterilized when processed as directed Validation applies to all identified steps provided in the processing instructions

9. Risk Analysis Medical device manufacturers must perform risk analysis to determine the appropriate content and level of detail in the processing instructions. Risk management shall be conducted according to ISO 14971 Nature and design of the medical device Nature of the contamination on the medical device• intended use life cycle of the medical device Foreseeable user error and misuse User training Equipment required for processing accessories and consumables required for processing; Necessary maintenance, limitations and post market Information of the medical device.

10. Provision of Information Manufacturers shall provide clear, validated instructions for the processing of their medical devices, ensuring safety and effectiveness after reuse or prior to use. Key information areas: • Initial treatment at point of use • Preparation before cleaning • Cleaning (automated and/or manual methods) • Disinfection (if applicable) • Drying, inspection, and maintenance • Packaging and sterilization • Storage and transportation conditions

11. Processing Instructions Requirements Manufacturers shall specify at least one validated method for each relevant stage of the device’s processing. Critical Information to Include When essential to maintain device function and user/patient safety, the following shall be stated: Detailed process steps Description of necessary equipment and/or accessories Defined process parameters and their tolerances

12. Processing Instructions Initial Treatment at Point of Use If required for effective processing, the following must be provided: Description of initial treatment techniques Required checks or inspections Maximum allowed time delay between use, initial treatment, and next step Details of support systems or transport containers Clear instructions on transportation steps

13. Processing Instructions Preparation Before Cleaning If pre-cleaning steps are necessary, the following shall be stated: Description of disassembly procedures Instructions for device preparation Guidance on testing procedures Pre-cleaning techniques and steps List of required accessories and tools

14. Processing Instructions Cleaning Manufacturers must provide at least one validated cleaning method for each device. Automated Cleaning method shall be preferred. If not applicable then manufacturer must provide validated manual method. Automated Cleaning Method (ISO 15883): If compatible with washer-disinfector: Specify only device-specific parameters, such as: Load configuration, positioning, accessories, chemicals, pressure, temperature Include statement confirming ISO 15883 conformity.

15. Processing Instructions Automated Cleaning Method (ISO 15883): If not generically compatible: Provide details on: Cleaning steps and parameter limits Accessories required Chemical identity & concentration Contact time Water quality Rinsing techniques Incompatibilities (if known)

16. Processing Instructions Manual Cleaning If manual method is required: Provide: Step-by-step instructions Process parameters & limits Required accessories or tools

17. Processing Instructions Disinfection Instructions If disinfection is required, manufacturers must provide at least one validated method. General Requirements Prefer automated disinfection If automated method is unsuitable, provide a validated manual method Disinfection may be an intermediate or terminal step in processing

18. Processing Instructions Automated Disinfection (ISO 15883) If using a washer-disinfector: Specify device-specific parameters: Load configuration, accessories, chemical type, pressure, temperature. Include statement confirming compatibility with ISO 15883 If not compatible then provide: Process steps & parameter limits Required accessories Chemical ID & concentration Contact time, Water quality, Rinsing techniques Known incompatibilities with disinfection agents

19. Processing Instructions Manual Disinfection If manual disinfection is required, include: Step-by-step instructions Parameter limits for device safety Needed tools/accessories Chemical details & concentration Required contact time Water quality standards Rinsing steps Known chemical incompatibilities

20. Processing Instructions Drying If drying is required, the manufacturer must provide at least one verified method to ensure the device is ready for safe use or further processing. When drying is necessary, include the following: Description of the drying process and acceptable parameter limits List of required accessories for the drying step Specification of the drying agent used (if applicable) Description of drying techniques and any special instructions

21. Processing Instructions Inspection and Maintenance If required to ensure safe and proper function, manufacturers must provide inspection and maintenance guidance. Required Information (if applicable): Inspection method(s) and performance criteria focused on patient safety Instructions for adjustment, calibration, or both Type, quantity, and application method for lubricant Step-by-step reassembly instructions List of any special tools required for maintenance

22. Processing Instructions Packaging Instructions If packaging is required during or after processing, instructions must: Be compatible with all previous processing stages Be suitable for the medical device type and design

23. Processing Instructions Sterilization If a medical device is intended to be sterilized, the manufacturer shall specify at least one validated method of the following Compliant standard Sterilization: Moist heat (ISO 17665) low temperature steam formaldehyde (ISO 25424), ethylene oxide (ISO 11135) or dry heat (ISO 20857) And also, then provide device specific parameters such as: specific load configuration, accessories, pressure, time or temperature limit(s) and a statement confirming the recommended process standard.

24. Processing Instructions Sterilization Instructions Detailed Requirements If not fully standard-compatible, include: Techniques and processing parameters Required accessories Sterilizing agent identity, concentration, and temperature Limits on condensate contamination (moist heat/formaldehyde) Required humidity, exposure time, and pressure Any post-sterilization steps

25. Processing Instructions Storage Requirements Specify any time limits or environmental conditions for storage before use e.g., temperature, humidity, contamination risks Required only where applicable Transportation If special handling is needed: Describe movement requirements between locations Recommend use of racks, trays, or rigid containers to prevent damage

26. Limitations and Restrictions On Processing Manufacturers must inform processors of any known limitations that could impact the safety, performance, or lifespan of the medical device during repeated processing. If processing causes degradation (e.g., reduced functionality, biocompatibility), this must be clearly stated If the device has a limited service life based on n umber of processing cycle or Other end-of-life indicators then this information must be provided. If the device is incompatible with certain substances or conditions , this must also be disclosed

27. Presentation of the Information Manufacturers must ensure processing instructions are clearly communicated and readily accessible. Format and Accessibility Processing instructions must be provided If provided electronically, a printed version must be available upon request Content must comply with Clause 6 of ISO 17764-1 requirements Alternative Communication Methods Use alternate formats such as: User manuals Wall charts Symbols per ISO 15223-1 and ISO 7000 May be supplied separately or via digital platforms

28. Summary This Standard ISO 17664-1:2021, detailing manufacturer requirements to provide validated, clear instructions for processing reusable medical devices to ensure safety, effectiveness, compliance, and protection of patient and user health.

29. References International Organization for Standardization. ISO 17664-1:2021 . Processing of Health Care Products — Information to Be Provided by the Medical Device Manufacturer for the Processing of Medical Devices — Part 1: Critical and Semi-Critical Medical Devices. ISO, 2021.

30. Thank You