GB1588-2024

Medical glass thermometer

医用玻璃体温计

GB 1588-2024 は現行の中国強制国家規格です：Medical glass thermometer。業界：電子。テーマ：電気安全。施行日：2026年5月1日。

適用可否は製品範囲、認証ルート、所管当局の通知、移行規定によって異なります。コンプライアンス判断に使う前に、翻訳をご依頼いただくか公式情報源をご確認ください。

コンプライアンス概要

この概要は現在英語のみで提供しています。

適用範囲

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.

技術要求

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.

試験方法

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.

よくある質問

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.

適用のヒント

種別: 製品
CCS: C38
ICS: 11.040.55
所管部門: National Medical Products Administration
技術委員会: National Technical Committee on Medical Electrical Equipment of Standardization Administration of China