GB1588-2024

Medical glass thermometer

医用玻璃体温计

GB 1588-2024 ist eine gültige verbindliche chinesische Nationalnorm: Medical glass thermometer. Branchencluster: Elektronik. Schwerpunkt: Elektrische Sicherheit. Inkrafttreten: 1. Mai 2026.

Die Anwendbarkeit hängt vom Produktumfang, dem Zertifizierungsweg, Bekanntmachungen der Behörden und Übergangsregeln ab. Fordern Sie eine Übersetzung an oder prüfen Sie die Quelle, bevor Sie diesen Eintrag für Compliance-Entscheidungen nutzen.

Compliance-Überblick

Dieser Überblick ist derzeit nur auf Englisch verfügbar.

Geltungsbereich und Anwendbarkeit

This standard applies to medical glass thermometers designed for measuring human body temperature, specifically those featuring a temperature retention structure and a liquid sensing medium. It covers various configurations including triangular stick types, yuanbao-type stick types, and inner-scale types used for oral, axillary, or rectal measurements. It explicitly excludes veterinary and neonatal stick thermometers, which were present in previous versions. Manufacturers of clinical glass thermometers must verify if their product types fall under the defined dimensional and application categories.

Technische Anforderungen

The standard specifies stringent physical and chemical requirements for glass thermometers. It defines exact basic dimensions and form factors for different thermometer types, ensuring interchangeability and proper clinical fit. Manufacturers must adhere to precise structural tolerances for the glass tube, bulb, and overall length. Regarding the sensing liquid and capillary system, the standard mandates that the liquid column must not exhibit self-receding (自流), interruptions (中断), or be difficult to shake down (难甩). The glass material must be transparent, smooth, and free from defects like cracks, bubbles, or double capillaries that could impede reading accuracy. For graduation and scaling, the standard requires a minimum division value of 0.1°C with uniform spacing. Scale lines and numerical markings must be clear, durable, and correctly positioned. The indicating value tolerance is strictly controlled to ensure diagnostic reliability. Furthermore, the standard outlines specific marking requirements, including the mandatory verification mark and manufacturer details.

Prüfverfahren

Testing procedures involve visual inspection and tactile examination for appearance defects and structural integrity. Dimensional verification is conducted using steel rulers and vernier calipers. For thermal performance, standard thermometers and constant temperature baths are utilized to verify indicating values at critical points (e.g., 37°C and 41°C). The self-receding property is tested by heating and observing liquid column stability, while the difficult to shake down characteristic is evaluated using a centrifuge with a specific acceleration. Readings are typically taken using a magnifying glass to ensure precision.

Häufige Fragen

What products are regulated under GB 1588-2024?

The standard applies to medical glass thermometers with a temperature retention structure and liquid sensing medium, designed for human body temperature measurement. It covers specific types including triangular stick, yuanbao-type stick, and inner-scale thermometers for oral, axillary, or rectal use.

What are the main updates from the previous GB 1588-2001 version?

The 2024 revision removes veterinary and neonatal stick thermometers, updates basic dimension requirements, modifies scale plate and line width specifications, and deletes packaging, transportation, and storage clauses to focus strictly on product performance and safety.

How does GB 1588-2024 handle mandatory verification and safety warnings?

The standard mandates a mandatory verification mark on every device and requires specific safety warnings in the manual, such as prohibiting the swallowing of the sensing liquid and detailing leak handling procedures, which may differ from general ISO medical device documentation requirements.

The summary above provides a high-level overview of GB 1588-2024. To ensure complete compliance for your medical devices entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 1588-2024 today to access all detailed parameters, dimension tables, and testing procedures.

Hinweise zur Anwendbarkeit

Normtyp: Produkt
CCS: C38
ICS: 11.040.55
Zuständige Behörde: National Medical Products Administration
Technisches Komitee: National Technical Committee on Medical Electrical Equipment of Standardization Administration of China

Normbeziehungen

Ersetzt:GB 1588-2001