SIST EN 61168:1995

Overview

EN 61168:1994 - "Radiotherapy simulators - Functional performance characteristics" is a European/CENELEC-aligned standard (CLC) that defines the type tests manufacturers must perform during the design and construction of radiotherapy simulators. The standard focuses on establishing functional performance characteristics for therapy simulation equipment rather than prescribing on-site acceptance or commissioning tests at the user’s site. The accompanying technical report IEC 61170 is referenced as guidance, noting that many IEC test procedures can also be applied for site testing if required.

Keywords: EN 61168, radiotherapy simulators, functional performance characteristics, type tests, IEC 61170, therapy equipment.

Key Topics

• Purpose and scope: clarifies that requirements apply to manufacturer-conducted type tests at design and construction stages, not to routine site acceptance testing.
• Functional performance requirements: establishes the framework for verifying that simulator equipment meets declared operational characteristics before release.
• Test responsibility: places primary responsibility on the manufacturer to demonstrate conformity via documented type tests.
• Documentation and reporting: requires test records and technical documentation to support conformity claims and regulatory compliance.
• Relationship to site testing: references IEC 61170 as a technical report suggesting which manufacturer test procedures are suitable for on-site verification, without mandating site tests.

Applications

• Design verification: used by manufacturers to structure and document type testing during development and production.
• Quality assurance: supports internal QA programs to ensure simulators meet specified functional performance before shipment.
• Pre-market conformity: provides evidence for conformity assessment and regulatory submissions where applicable.
• Procurement and specification: helps hospitals and clinics define performance expectations in technical procurement documents.
• Test planning: serves as a baseline for developing detailed test protocols that may be adapted for site acceptance (with IEC 61170 guidance).

Keywords: manufacturer testing, quality assurance, acceptance testing, radiotherapy simulator performance.

Who Uses This Standard

• Medical device manufacturers of radiotherapy simulators
• Design and test engineers responsible for product verification
• Quality managers and regulatory affairs specialists
• Clinical engineers, hospital procurement teams, and acceptance-test contractors who reference manufacturer test data
• Test laboratories and conformity assessment bodies reviewing type-test evidence

Related Standards

• IEC 61170 (technical report): referenced for test procedures that can be applied to site testing and additional guidance.
• General medical device and radiotherapy equipment standards and regulations (refer to national and international healthcare device directives for full compliance context).

EN 61168 remains a practical reference for manufacturer-focused type testing of radiotherapy simulators, ensuring documented functional performance before equipment reaches clinical environments.