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[Legal calibration of ocular tonometers]
Summary
Mandatory tonometer verification was introduced in Germany in 1970. This paper details the legal framework for tonometer verification and type approval, listing all approved devices since 1970.
Area of Science:
- Ophthalmology
- Medical Device Regulation
Context:
- Introduction of mandatory tonometer verification in the Federal Republic of Germany in 1970.
- Establishment of regulatory requirements for medical devices.
Purpose:
- To describe the legal basis for tonometer verification and type approval.
- To provide a comprehensive list of approved tonometers.
Summary:
- Details the legal framework governing tonometer verification and type approval in Germany.
- Presents a historical record of tonometers approved since 1970.
Impact:
- Provides essential regulatory and historical information for ophthalmologists and medical device manufacturers.
- Ensures continued compliance and understanding of tonometer standards.