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ISO Certified Sterilization Machines

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ISO certified sterilization machines refer to autoclaves, ultrasonic cleaners, and sealing equipment that are manufactured under an ISO-certified Quality Management System (QMS), most commonly ISO 13485:2016 (Medical Devices - Quality management systems - Requirements for regulatory purposes). This certification confirms that the design, production, installation, and servicing of the equipment comply with stringent, internationally recognized standards for medical device quality. It provides assurance that the machine's performance is consistent, repeatable, and meets the required safety and efficacy standards (e.g., EN 13060 for small steam sterilizers). Purchasing ISO 13485 certified equipment is a fundamental requirement for healthcare providers and distributors operating in regulated markets, demonstrating due diligence in procuring high-quality, validated, and reliable infection control technology.

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Specification

ParameterDetail
Core CertificationISO 13485:2016 (Medical Devices QMS)
Product ComplianceCE Marking (MDD/MDR) and/or FDA Approval
Process ControlManufacturing Process Subject to Strict Audit Trails
Efficacy StandardMeets EN 13060 (Autoclaves) or Equivalent Standards
DocumentationDetailed Documentation of Design and Manufacturing History
Material TraceabilityFull Traceability of Critical Components (e.g., Pressure Vessel)
Service QualityService Procedures Must Also Adhere to QMS Standards
ApplicationRequired for All Regulated Healthcare Environments

Application

This equipment is essential for all regulated healthcare environments globally, including hospitals, dental chains, ambulatory surgery centers, and certified sterile processing departments (CSSD). For distributors, selling ISO 13485-certified machinery minimizes the risk of product recalls and regulatory non-compliance. For end-users, it guarantees that the sterilizer is manufactured under strict quality controls, leading to higher reliability and consistent performance. When a healthcare facility undergoes an accreditation survey or regulatory audit, the certification of its sterilization equipment is a key piece of documentation, providing confidence that the physical equipment is capable of performing validated sterilization cycles repeatedly and safely. The commitment to ISO standards underpins the integrity of the entire infection control process.

Transaction Details

For ISO-certified equipment, payment terms are standard (T/T deposit, balance against documents), but the focus is on the documentation. We provide copies of the ISO 13485 certificate and specific product compliance declarations (e.g., CE) with every shipment. Shipping is via secured, insured freight. Lead times reflect the rigorous QC process. We offer premium pricing commensurate with the guaranteed quality and compliance. Buyers should request access to the Device History Record (DHR) or specific traceability documentation for critical components (like the pressure vessel) upon delivery. The warranty is robust, backed by the manufacturer's commitment to quality management systems, ensuring that any necessary repair or service is also performed under controlled, documented procedures.

Advantage

The primary advantage is guaranteed quality, reliability, and regulatory confidence. ISO 13485 certified manufacturing means that the risk of component failure is minimized, and performance specifications (like temperature accuracy and cycle repeatability) are strictly controlled. This results in maximum uptime for the critical sterilization function, reducing the potential for patient scheduling delays. Furthermore, the certification simplifies the equipment validation process for the end-user, as the manufacturer provides detailed, audited documentation. Investing in ISO-certified equipment is the most effective way to protect a healthcare facility's reputation, reduce legal liability from sterilization failures, and ensure the long-term, cost-effective operation of the device in demanding clinical settings.

FAQ

  • Q: Does ISO 13485 certify the sterilization cycle itself?
  • A: No. ISO 13485 certifies the *manufacturer's quality management system*. The sterilization cycle's efficacy must be certified by standards like EN 13060 (autoclaves) and validated through the user's ongoing performance monitoring (e.g., B-D tests).
  • Q: Why is ISO 13485 important for distributors?
  • A: It provides distributors with the necessary due diligence and documentation to import and sell the equipment in regulated markets (like the EU or US), simplifying their regulatory burden and reducing liability exposure.
  • Q: How often must the manufacturer renew the ISO 13485 certification?
  • A: The ISO 13485 certification is subject to annual surveillance audits by a third-party registrar and requires complete recertification every three years, ensuring continuous compliance.
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Wanrui Medical Instrument

Our products are mainly exported to over 30 countries such as USA,Germany,Japan,Spain,Italy,UK,Korea,Australia,Canada，Iraq,Algeria and etc. Ningbo Wanrui obtains customer's trust through honesty and sincerity, and redounds on customers by superior quality & high-tech product. We commit our selves to making friends both in China and oversea by our exceptional products and complete service service! "Keep improving, serve our customers" is our goal, we sincerely look forward to cooperating with you!
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86-15728040705
86-18957491906

86-15728040705
86-18957491906