Tıbbi cihaz sektörü için Mecmesin çözümleri.

Tıbbi cihaz üreticileri, hasta güvenliğinin kritik olduğu dünyanın en rekabetçi ve yüksek düzeyde düzenlenmiş endüstrilerinden birinde çalışır.

Ürün güvenilirliği ve ömürleri, standartlara uygunluk, pazara çıkış süresi ve izlenebilirlik konularına bağlıdır.

Mecmesin kuvveti ve tork test sistemleri, her türlü tıbbi cihazın fiziksel gücünü test etmek için idealdir. Test yazılımımız, ham verilerin tam depolanması, sağlam bir denetim izi, tam operatör güvenliği ve garantili tekrarlanabilirlik ile izlenebilir sonuçlar sağlar.

Luer konektörlerinin tork bütünlüğünü, şırıngaların kayma kuvvetini, ilaç verme cihazlarının fiziksel gücünü, protez eklemlerini ve kemik vidalarını test edip etmediğini; Mecmesin test cihazları, kullanımı kolay ve uygun fiyatlı bir çözüm sunar.

ASTM, BS EN, ISO, DIN, CEN, Ph. Eur. ve USP standartları

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Featured case studies

Standards

Featured or equivalent test standards for Mecmesin solutions in this section

ASTM D2063/D2063M

Standard Test Methods for Measurement of Torque Retention for Packages with Continuous Thread Closures Using Non-Automated (Manual) Torque Testing Equipment

ASTM D2659

Standard Test Method for Column Crush Properties of Blown Thermoplastic Containers

ASTM D3577

Standard Specification for Rubber Surgical Gloves

ASTM D3578

Standard Specification for Rubber Examination Gloves

ASTM D412-16

Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— Tension1

ASTM D7860-14

Standard Test Methods for Measurement of Torque Retention for Child Resistant and Non-Child Resistant Packages with Continuous Thread Closures Using Automated Torque Testing Equipment

ASTM D7860-14

Standard Test Methods for Measurement of Torque Retention for Child Resistant and Non-Child Resistant Packages with Continuous Thread Closures Using Automated Torque Testing Equipment

ASTM F2132-01

Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps

ASTM F2824-10

Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids

ASTM F88/F88M

Standard Test Method for Seal Strength of Flexible Barrier Materials

ASTM F88/F88M

Standard Test Method for Seal Strength of Flexible Barrier Materials

BS 7548

Specification For Sterile, Single-use Syringes, With Or Without Needle, For Insulin Injection

BS EN 14477

Packaging. Flexible packaging material. Determination of puncture resistance. Test methods

BS EN 868-5

Packaging materials and systems for medical devices which are to be sterilized. Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods

BS EN ISO 80369-20

Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods

BS EN ISO 11608-3

Needle-based injection systems for medical use. Requirements and test methods. Finished containers

BS EN ISO 11608-3

Needle-based injection systems for medical use. Requirements and test methods. Finished containers

BS EN ISO 11608-3

Needle-based injection systems for medical use. Requirements and test methods. Finished containers

BS EN ISO 13127

Packaging. Child resistant packaging. Mechanical test methods for reclosable child resistant packaging systems

BS EN ISO 7886-1

Sterile hypodermic syringes for single use Part 1: Syringes for manual use

BS EN ISO 80369-7

Small-bore connectors for liquids and gases in healthcare applications - Part 7 connectors for intravasular or hypodermic applications

BS ISO 11040-4

Pre-filled Syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

BS ISO 11040-4

Pre-filled Syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

BS ISO 11040-4

Pre-filled Syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

BS ISO 11040-4

Pre-filled Syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

BS ISO 11040-4

Pre-filled Syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

BS ISO 11040-4

Pre-filled Syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

ISO 11607-1

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 374-4

Protective gloves against dangerous chemicals and micro-organisms — Part 4: Determination of resistance to degradation by chemicals

ISO 8362-7

Injection containers and accessories — Part 7: Injection caps made of aluminiumplastics combinations without overlapping plastics part

USP 1207.3

USP 1207.3 - Package Integrity Evaluation - Sterile Products

Medical Devices industry brochure

Safety requirements for medical devices and pharmaceuticals are paramount as they are predominantly used on humans. This puts a heavy emphasis on quality control during development, production and packaging.

Download our latest industry brochure for medical device force and torque testing solutions.

Download Medical Devices industry brochure

Mecmesin | Medical Devices industry brochure