SIST EN 12470-3:2000/kprA1:2009

Overview

SIST EN 12470-3:2000/kprA1:2009 is a European standard developed by CEN/TC 205, focusing on the performance of compact electrical clinical thermometers with maximum reading devices. It specifically covers both non-predictive and predictive thermometers used for measuring human body temperature. This standard provides an essential framework for manufacturers to ensure the safety, reliability, and accuracy of electrical clinical thermometers used in medical diagnostics.

This amendment enhances key aspects such as probe cover labeling, marking requirements, and instructions for use, aligning the standard with the latest safety protocols and EU directives. It supports conformity with EU Directive 93/42/EEC on medical devices, enabling compliance within the European Economic Area.

Key Topics

• Scope and Application: Applies to compact electrical thermometers incorporating a maximum device, used for clinical human body temperature measurement.

• Normative References: Updates titles and references of related standards such as EN 980 (labeling symbols for medical devices) and EN 60601-1 (medical electrical equipment safety).

• Probe Cover Requirements:

  • Single-use probe covers must display a clear indication of their disposable nature, consistent across the European Community.

• Marking and Labeling:

  • Manufacturers must include the name and address of an authorized representative if they lack a registered business presence within the EU.
  • Updated requirements ensure traceability and clear identification, aiding regulatory compliance.

• Instructions for Use:

  • Must state the date of issue or latest revision.
  • Include authorized representative contact information when applicable.
  • Provide information on risks related to re-use of devices or components, critically important for infection control.

• Relationship to EU Directives:

  • Annex ZA clarifies links to the Essential Requirements of EU Directive 93/42/EEC, facilitating harmonization and legal conformity.

Applications

SIST EN 12470-3:2000/kprA1:2009 is applicable to manufacturers, healthcare providers, and regulatory bodies involved in the production, marketing, and use of compact electrical clinical thermometers with maximum reading capability. Practical applications include:

• Medical Device Manufacturing: Guidelines for developing thermometers that meet safety, performance, and labeling standards to enter the European market.

• Healthcare Settings: Ensuring clinical thermometers used in hospitals, clinics, and primary care meet regulatory expectations for accuracy and patient safety.

• Regulatory Compliance: Assisting national standard bodies and notified bodies in evaluating conformity with EU medical device regulations.

• Quality Assurance: Supporting quality management in healthcare device production by setting performance benchmarks for electrical thermometers.

Related Standards

EN 12470 is a multipart series addressing different types of clinical thermometers, including:

• EN 12470-1: Metallic liquid-in-glass thermometers with maximum device
• EN 12470-2: Phase change-type (dot matrix) thermometers
• EN 12470-4: Electrical thermometers for continuous measurement
• EN 12470-5: Infra-red ear thermometers with maximum device

Additionally, compliance with EN 60601-1 (Medical electrical equipment - general safety and essential performance) is integral to ensuring device reliability and patient safety.

Keywords: clinical thermometers, compact electrical thermometers, medical device standards, EN 12470-3, European standard, maximum device thermometer, medical electrical equipment, probe cover labeling, EU Directive 93/42/EEC compliance, healthcare thermometer performance, medical thermometer safety.