Recognized/Harmonized Standard Verification Form – ISO 17664-2:2021
What is a Recognized/Harmonized Standard Verification Form – ISO 17664-2:2021?
This template enables you to demonstrate objective evidence with all relevant reprocessing requirements set out in ISO 17664-2:2021.
It contains cross-reference tables for the applicable MDD essential requirements and MDR general safety and performance requirements (GSPR).
Why do you need it?
If your device is reprocessable, proper process validations and instructions for use are essential, both for product safety and regulatory submissions.
Using this template as verification evidence is an easy and straight forward way to show compliance with the standard.
MDR Annex II 4 (d) requires “the precise identity of the controlled documents offering evidence of conformity with each harmonised standard, common specification or other method applied to demonstrate conformity with the general safety and performance requirements”.
By using our template as controlled document you can easily fulfill this requirement.
How to use it?
- Buy the template and download it straight away.
- Fill in all tables and reference your evidence documentation, e.g. process validation test reports or instruction for use sections. The instructional text within the templates helps you.
- Sign it, file it in your technical documentation and reference it in your Essential Requirement / GSPR Checklist.
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Table of Content
SECTION 1: GENERAL INFORMATION
1.2 Device Information
1.3 Terms, Abbreviations & Acronyms
SECTION 2: APPLICABILITY
SECTION 3: REQUIREMENTS COVERED BY THIS VERIFICATION FORM
3.1. Design Input
SECTION 4: RISK MANAGEMENT
SECTION 5: PROCESS VALIDATION REQUIREMENTS
SECTION 6: INFORMATION TO BE PROVED
6.2 Processing Instructions
6.3 Limitations and Restrictions
6.4 Preparation before Processing
6.5.2 Manual Cleaning
6.5.3 Automated Cleaning
6.6.2 Manual Disinfection
6.6.3 Automated Disinfection
6.8 Inspection & Maintenance
SECTION 7: PRESENTATION OF INFORMATION
SECTION 8: CONCLUSION
SECTION 9: DOCUMENT REVISION HISTORY
Number of Pages