Medical & Healthcare Plastics Specification Template

specification

Comprehensive specification template for medical and healthcare plastics covering biocompatibility requirements, regulatory compliance, sterilization compatibility, and quality standards. Essential for medical device manufacturers and pharmaceutical packaging companies.

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Material Type

Grade

Supplier

Lot Number

USP Class VI Compliance

ISO 10993 Testing Required

Cytotoxicity Result

FDA Status

USP Biological Reactivity

EU MDR Compliance

Gamma Radiation Compatible

Max Gamma Dose (kGy)

EtO Compatible

Max Autoclave Temperature

Tensile Strength (MPa)

Flexural Modulus (MPa)

Izod Impact (J/m)

Lot Traceability Required

Certificate of Analysis

Storage Conditions

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Basic Material Information

Material Type: Polycarbonate Grade: Medical Grade PC Supplier: Colorado Sun Inc Lot Number: LOT-2024-001 Manufacture Date: {{manufactureDate}} Expiration Date: {{expirationDate}}

Biocompatibility Requirements

USP Class VI Compliance: Required - Certificate Available ISO 10993 Testing: Parts 5, 10, 11 Cytotoxicity (ISO 10993-5): Pass - Non-cytotoxic Sensitization (ISO 10993-10): {{sensitization}} Irritation (ISO 10993-10): {{irritation}} Systemic Toxicity (ISO 10993-11): {{systemicToxicity}}

Regulatory Compliance

FDA Status: FDA Compliant - 21 CFR 177.1580 USP <661> Biological Reactivity: Class VI - Meets Requirements EU MDR Compliance: Compliant - Annex I ISO 13485 Manufacturing: {{iso13485}} Change Control Protocol: {{changeControl}} DMF Number: {{dmfNumber}}

Sterilization Compatibility

Gamma Radiation: Yes (25 kGy max) Ethylene Oxide (EtO): Yes Steam Autoclave: {{autoclaveCompatible}} (121°C max) E-Beam: {{ebeamCompatible}} Vaporized Hydrogen Peroxide: {{vhpCompatible}} Post-Sterilization Aging: {{agingRequirements}}

Physical Properties

Tensile Strength: 65 MPa Flexural Modulus: 2400 MPa Izod Impact: 850 J/m Heat Deflection Temperature: {{hdt}}°C @ {{hdtLoad}} MPa Vicat Softening Point: {{vicat}}°C Transparency: {{transparency}}

Quality Control Requirements

Lot Traceability: Full chain of custody documentation Certificate of Analysis: Required with each shipment Statistical Process Control: {{spc}} Incoming Inspection: {{incomingInspection}} Storage Conditions: 23°C ± 2°C, <60% RH Shelf Life: {{shelfLife}}

When to Use This Template

•Specifying biocompatible resins for medical device housings and components
•Pharmaceutical packaging material qualification and supplier approval
•Contract manufacturer material specifications for healthcare applications
•Regulatory submission documentation for medical device plastic components
•Quality control specifications for cleanroom molding operations