EN 27740:1992
(Main)Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
Lays down the dimensions of two sizes of fitting features for detacheable scalpel blades and the handles with which they are used. It secures a good fitting and interchangeability of detachable blades for scalpels manufactured in different countries or by different manufacturers. The transitional period for a gradual adaption of the fitting dimensions specified in this standard should end with the year 1990.
Chirurgische Instrumente, Skalpelle mit auswechselbaren Klingen, Paßmaße (ISO 7740:1985)
Instruments chirurgicaux, bistouris à lames détachables, dimensions d'assemblage (ISO 7740:1985)
La présente Norme internationale fixe les dimensions de deux types d'assemblages de lames détachables et de manches de bistouris correspondants.
Kirurški instrumenti, skalpeli s snemnimi rezili, mere nastavkov (ISO 7740:1985)
General Information
- Status
- Published
- Publication Date
- 21-May-1992
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Drafting Committee
- CEN/TC 205 - Non-active medical devices
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 07-Sep-2007
- Completion Date
- 07-Sep-2007
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
Overview
EN 27740:1992 is a European standard that specifies the fitting dimensions for scalpels with detachable blades used in surgical procedures. Based on ISO 7740:1985, this standard ensures that scalpels and their interchangeable blades manufactured in different countries or by various manufacturers can fit together reliably and securely. By defining precise dimensional requirements for scalpel handles and detachable blades, EN 27740:1992 promotes uniformity, compatibility, and safety in surgical instrument design.
This standard was published under the authority of CEN (European Committee for Standardization), and its transitional period for adoption concluded in 1990. It remains a key reference for manufacturers and healthcare providers who rely on standardized instruments to maintain high surgical quality and interoperability.
Key Topics
- Fitting Dimensions: Defines two sizes of fitting features on scalpel handles and detachable blades, ensuring a secure attachment.
- Interchangeability: Allows interchangeable use of scalpel blades from different manufacturers without compromising fit or safety.
- Compatibility: Supports international standardization by aligning with ISO 7740:1985 dimensions.
- Surgical Instrument Safety: Enhances surgical instrument reliability by minimizing blade detachment risks through standardized fitting.
- Transitional Adoption: Provides guidelines for manufacturers to gradually adopt these dimensions, with completion targeted by 1990.
Applications
EN 27740:1992 is essential for several practical applications in the medical and manufacturing fields:
- Surgical Equipment Manufacturing: Enables production of scalpels and blades that meet international dimension standards, facilitating global trade and use.
- Healthcare Facilities: Assures hospitals and surgical centers that scalpels from different suppliers are compatible with standard handles.
- Medical Device Procurement: Helps procurement teams specify compliant instruments, improving safety and consistency in surgical tools.
- Quality Control: Assists manufacturers in implementing dimensional checks during the production process to comply with standardized fitting requirements.
Related Standards
- ISO 7740:1985 – The foundational international standard detailing dimensions of scalpels with detachable blades, directly referenced by EN 27740:1992.
- EN ISO 13485 – Specifies requirements for a quality management system for medical device manufacturers, including surgical instruments.
- ISO 9626 – Stainless steel needle specifications, relevant to surgical tool manufacturing processes.
- ISO 7153-1 – Covers stainless steel for surgical instruments, complementing standards on physical design like EN 27740.
By adhering to EN 27740:1992, manufacturers and healthcare professionals ensure that surgical scalpels with detachable blades achieve safe, compatible, and standardized performance worldwide. This standard plays a critical role in the global interoperability of surgical instruments, ultimately contributing to higher patient safety and surgical efficiency.
Frequently Asked Questions
EN 27740:1992 is a standard published by the European Committee for Standardization (CEN). Its full title is "Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)". This standard covers: Lays down the dimensions of two sizes of fitting features for detacheable scalpel blades and the handles with which they are used. It secures a good fitting and interchangeability of detachable blades for scalpels manufactured in different countries or by different manufacturers. The transitional period for a gradual adaption of the fitting dimensions specified in this standard should end with the year 1990.
Lays down the dimensions of two sizes of fitting features for detacheable scalpel blades and the handles with which they are used. It secures a good fitting and interchangeability of detachable blades for scalpels manufactured in different countries or by different manufacturers. The transitional period for a gradual adaption of the fitting dimensions specified in this standard should end with the year 1990.
EN 27740:1992 is classified under the following ICS (International Classification for Standards) categories: 11.040.30 - Surgical instruments and materials. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 27740:1992 has the following relationships with other standards: It is inter standard links to EN 27740:1992/A1:1997, EN 27740:1992/AC:1996. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 27740:1992 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2000
Kirurški instrumenti, skalpeli s snemnimi rezili, mere nastavkov (ISO 7740:1985)
Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO
7740:1985)
Chirurgische Instrumente, Skalpelle mit auswechselbaren Klingen, Paßmaße (ISO
7740:1985)
Instruments chirurgicaux, bistouris a lames détachabl
...
La norme EN 27740:1992, qui traite des instruments chirurgicaux, en particulier des scalpels à lames détachables, est un document clé dans le domaine de la santé et de la chirurgie. Elle établit des dimensions précises pour deux tailles de caractéristiques d'ajustement pour les lames détachables de scalpels, ainsi que pour les poignées qui leur sont associées. L'une des principales forces de cette norme réside dans son objectif de garantir un bon ajustement et une interchangeabilité effective des lames détachables pour les scalpels, indépendamment du pays de fabrication ou du fabricant. Cela est particulièrement pertinent dans un contexte où la standardisation contribue à la sécurité des patients et à l'efficacité des procédures chirurgicales. La norme facilite ainsi l'approvisionnement et l'utilisation d'instruments chirurgicaux de manière cohérente. Un autre point fort de la norme réside dans sa portée temporelle, ayant prévu une période transitoire pour l'adaptation progressive des dimensions d'ajustement spécifiées jusqu'en 1990. Cela démontre la vision anticipée des concepteurs de la norme, en reconnaissant l'importance d'une période de transition pour augmenter l'acceptation et l'implémentation des nouvelles spécifications techniques. Dans l'ensemble, EN 27740:1992 est d'une grande pertinence pour les fabricants d'instruments chirurgicaux, les professionnels de la santé et les organismes de réglementation, car elle assure que les normes de qualité et de sécurité soient respectées à travers différents contextes de fabrication et d'utilisation. La standardisation jouant un rôle crucial dans l'optimisation des procédures chirurgicales, cette norme représente un pas significatif vers l'amélioration des pratiques dans le secteur médical.
SIST EN 27740:2000は、外科手術用器具に関する重要な標準規格であり、取り外し可能なブレードを持つメスの適合寸法を扱っています。この規格の主な焦点は、異なるメーカーや国で製造されたメスのブレードの適合性と互換性を確保することです。具体的には、2つのサイズの取り付け機能の寸法を明記しており、これにより医療現場での効率的な手術が可能となります。 この標準の強みは、取り外し可能なブレードとハンドルとの間の良好な適合を確保する点にあります。医療機器の交換性は、患者の安全性や手術の成功に直結しており、EN 27740:1992はその基盤を提供します。また、1990年までに適合寸法の順次適応を求めていることから、時間的な適応も考慮されており、国際的な標準に則った製品開発を促進します。 この規格は、特に外科手術用メスを使用する医療従事者や製造業者にとって、国際的な基準に基づいた製品設計や品質管理を行う際の指針となります。これにより、医療業界全体の品質向上に寄与し、患者に対する医療サービスの向上を実現します。したがって、SIST EN 27740:2000は、外科手術器具の分野において非常に重要な意味を持つ標準規格です。
The standard EN 27740:1992 lays down precise dimensions for two sizes of fitting features designed for detachable blades used in surgical scalpels. This document is essential as it ensures compatibility and interchangeability among scalpel blades manufactured by different companies across various countries, thereby promoting a standard level of quality and safety in surgical instruments. One of the significant strengths of EN 27740:1992 is its focus on adaptability. By specifying the fitting dimensions of scalpel blades and their handles, it mitigates the risks associated with using non-conforming parts in surgical settings. This standardization facilitates a seamless integration of products from different manufacturers, enhancing the operational efficiency of healthcare providers. Another strength lies in the historical context offered by the transitional period concluding in 1990. This aspect reflects the standard’s relevance, anticipating the industry’s need for gradual adaptation. By setting a clear timeline for compliance, stakeholders in the medical field were encouraged to upgrade their products and procedures, ensuring patient safety and the efficacy of surgical operations. In summary, the relevance of EN 27740:1992 extends beyond mere dimensional specifications; it fosters an environment of uniformity in surgical instruments, which is crucial for enhancing surgical practices globally. The emphasis on ensuring good fitting and interchangeability is pivotal for reducing complications arising from mismatched components, making this standard a cornerstone in the development of reliable surgical tools.
Die Norm EN 27740:1992 legt die Dimensionen von zwei Größen der Anpassungsmerkmale für abnehmbare Skalpelle und die dazugehörigen Griffe fest. Diese Standardisierung ist von wesentlicher Bedeutung, da sie eine qualitativ hochwertige Passform und die Interoperabilität abnehmbarer Klingen für Skalpelle sichert, die in verschiedenen Ländern oder von unterschiedlichen Herstellern produziert werden. Durch die Festlegung dieser Maße wird sichergestellt, dass medizinisches Personal weltweit auf Standardprodukte zurückgreifen kann, ohne Kompromisse bei der Qualität oder Sicherheit eingehen zu müssen. Ein entscheidender Stärke dieser Norm ist ihre Fähigkeit, eine einheitliche Basis für die Herstellung und den Austausch von chirurgischen Instrumenten zu schaffen. Dies fördert nicht nur die Effizienz in betrieblichen Abläufen, sondern minimiert auch potenzielle Risiken, die durch inkompatible Produkte entstehen könnten. Durch die klare Definition der Passungsdimensionen wird eine erhebliche Reduzierung von Fehlern erreicht, die bei der Verwendung von nicht standardisierten Klingen und Griffen auftreten könnten. Die Relevanz der EN 27740:1992 ist für die Medizintechnik nicht zu unterschätzen. In einem Bereich, in dem Präzision und Sicherheit von höchster Wichtigkeit sind, leistet diese Norm einen wertvollen Beitrag zur Gewährleistung von Qualitätsstandards in der chirurgischen Praxis. Die Übergangsfrist für die schrittweise Anpassung der in dieser Norm festgelegten Anpassungsdimensionen sollte bis zum Jahr 1990 enden, was auf eine proaktive Herangehensweise an das normgerechte Arbeiten hinweist. Insgesamt stärkt die EN 27740:1992 die Marktposition von Herstellern, die sich an diese Standards halten, und fördert das Vertrauen der Anwender in die Zuverlässigkeit und Sicherheit der verwendeten chirurgischen Instrumente.
표준 EN 27740:1992는 수술 기구 중 덮개가 탈착 가능한 날에 대한 치수 기준을 제시하고 있습니다. 이 표준의 범위는 두 가지 사이즈의 탈착 가능한 스칼펠 블레이드와 그에 적합한 핸들의 치수를 명확히 규정하여, 서로 다른 나라에서 제조되거나 제조사에 따라 달라질 수 있는 스칼펠 블레이드 간의 적합성과 교환 가능성을 보장합니다. 이 표준은 특히 의료 기기를 다루는 제조업체들에게 매우 중요한 기준이 되며, 전 세계적으로 의료 기기의 일관성을 확보하는 데 기여합니다. EN 27740:1992는 탈착 가능한 블레이드의 핸들과의 적합도를 보장함으로써 수술 시 사용자의 신뢰성을 높이고, 다양한 제조업체의 제품 간의 호환성을 확대합니다. 추가적으로, 이 표준은 덮개가 탈착 가능한 스칼펠 블레이드의 기초적인 설계를 규명하여, 제조 과정에서의 효율성을 증대시키고, 제품 개발 시 발생할 수 있는 오류를 최소화하는 데 큰 도움을 줍니다. 이 표준의 강점은 명확하게 정의된 치수로 인해 다양한 스칼펠과 블레이드 간의 일관성을 유지할 수 있다는 점입니다. 또한, 모든 제조업체가 동일한 기준을 따라 제품을 설계하고 제작할 수 있도록 하여, 국제적으로도 품질 보증을 가능하게 합니다. 이러한 측면에서 EN 27740:1992는 현대 수술 기구의 표준에 필수적인 역할을 하며, 의료 분야의 발전에 긍정적인 기여를 하고 있습니다. 이 문서는 수술 기구에 대한 표준화를 통해 사용자와 환자 모두에게 신뢰성 있는 의료 환경을 제공하는 데 기여하고 있으며, 덮개가 탈착 가능한 스칼펠 블레이드와 핸들과의 조화를 보장하는 중요한 기준으로 자리잡고 있습니다.
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